Compliance Specialist StefaniniCompliance SpecialistRaleigh, NC$25–$29 / hourTemporaryContractorOur presence is in countries like the Americas, Europe, Africa, and Asia, and more than four hundred clients across a broad spectrum of markets, including financial services, manufacturing, telecommunications, chemical services, technology, public sector, and utilities. Change Management Support: Represent business operations in change-management discussions by providing operational supporting documentation updates and helping ensure implementation activities align with established QARA guidance.
Deposit Quality Control Specialist I State Employees' Credit UnionDeposit Quality Control Specialist IRaleigh, North CarolinaThe Deposit Quality Control Specialist I (DQCSI) is an entry-level position that performs quality control (QC) activities to identify procedural and regulatory deviations/violations in deposits and payments related activities performed in branches, Member Services Support and Deposits and Operations business lines. 10% - Utilize awareness of changes in processes and regulatory landscape to help identify processes requiring deposit monitoring and assist applicable business lines and QC leadership to develop and implement monitoring solutions.
NewSr Specialist, Quality Control-Microbiology Kyowa KirinSr Specialist, Quality Control-MicrobiologySanford, NC$116,000–$152,300 / yearEstablish key operational processes within the QC Microbiology Lab including: Laboratory gowning requirements, personnel and materials flow; sample receipt, processing, and disposal; Inventory management (i.e., ordering, receive, qualification, and release of critical lab supplies and consumables; Laboratory safety, Laboratory Waste management and disposal, Laboratory cleaning). Collaborate cross-functionally in the site early-stage activities, including identification and review of user requirements; prioritization for implementation of equipment, instruments and analytical methods required for facility start-up and selected electronic Quality Systems for operation (LIMS/ELN/LES).
Quality Control Data Review Specialist - Weekend 1st Shift Alcami CorporationQuality Control Data Review Specialist - Weekend 1st ShiftMorrisville, North CarolinaFull timeThese activities may include reviewing documents and data, conducting basic floor audits and process inspections, consulting on quality and compliance issues, maintaining quality databases and performing trend analysis where needed, and performing quality and compliance-oriented training as necessary. Qualifications: Bachelor’s degree in Chemistry, Biology, or related field with 2+ years GMP related experience; OR Master’s degree in related field with 1+ years related experience; OR equivalent education and work experience.
Quality Control Data Review Specialist - 2nd Shift Alcami CorporationQuality Control Data Review Specialist - 2nd ShiftMorrisville, North CarolinaFull timeThese activities may include reviewing documents and data, conducting basic floor audits and process inspections, consulting on quality and compliance issues, maintaining quality databases and performing trend analysis where needed, and performing quality and compliance-oriented training as necessary. Qualifications: Bachelor’s degree in Chemistry, Biology, or related field with 2+ years GMP related experience; OR Master’s degree in related field with 1+ years related experience; OR equivalent education and work experience.
NewSenior Principal Quality Control Specialist, Master Data Genentech IncSenior Principal Quality Control Specialist, Master DataHolly Springs, NC$128,000–$238,000 / yearYou possess a working understanding of database management/relational tables, preferably with experience working with Labware (LIMS), Binova (LES), SAP, Mettler Toledo LabX, Waters Empower Chromatography Data System or similar cGMP QC systems. This plant meets today's demand for CVRM (Cardiovascular, Renal, and Metabolism) medicines and is scalable to grow with the portfolio, which focuses on next-generation metabolic medicines specifically targeting the global obesity epidemic and Type 2 diabetes.
Principal Quality Control Specialist, Master Data Genentech IncPrincipal Quality Control Specialist, Master DataHolly Springs, NC$98,000–$182,000 / yearYou possess a working understanding of database management/relational tables, preferably with experience working with Labware (LIMS), Binova (LES), SAP, Mettler Toledo LabX, Waters Empower Chromatography Data System or similar cGMP QC systems. This plant meets today's demand for CVRM (Cardiovascular, Renal, and Metabolism) medicines and is scalable to grow with the portfolio, which focuses on next-generation metabolic medicines specifically targeting the global obesity epidemic and Type 2 diabetes.
Specialist, Quality Control - Physical Chemistry Novartis AGSpecialist, Quality Control - Physical ChemistryDurham, NC$41.06–$76.25 / hourKey Responsibilities: Execute routine and non-routine analysis for cGMP release and characterization testing using techniques including but not limited to chromatography (HPLC, UPLC), AUC, SEC, compendial assays (pH, Conductivity, Osmolality), electrophoresis (CE, Western Blot) and assist with data review. Essential Requirements: Bachelors degree in scientific disciplines such as Biochemistry, Biology, Microbiology or related field with 5 years' experience in GMP environment or 4 years' at GTx.
Senior Specialist 2, Quality Control Instrumentation FUJIFILM Biotechnologies USA IncSenior Specialist 2, Quality Control InstrumentationHolly Springs, NCPrior hands-on experience with analytical instrumentation, including but not limited to UPLC/HPLC (Ultra/High-Performance Liquid Chromatography), Capillary Electrophoresis/Imaged Capillary Isoelectric Focusing (iCIEF), Gel Electrophoresis/Western Blot, Plate Readers, qPCR (Quantitative Polymerase Chain Reaction), Spectrophotometry, and Mass Spectrometry. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place.
NewQuality Control Validation Area Specialist I Novo Nordisk ASQuality Control Validation Area Specialist IClayton, NCYou will be joining Fill & Finish Expansions (FFEx), which is responsible for all major expansion activities within aseptic production, solid dosage forms, finished products, fill & finish warehousing, and QC across all production areas in Product Supply. May consider Associates Degree in Life Sciences, Chemistry, Engineering or a relevant field of study from an accredited university with a minimum of four (4) years of instrument, laboratory validation, or engineering experience in the pharmaceutical industry or related field required.
Specialist, Quality Control Instrumentation FUJIFILM Biotechnologies USA IncSpecialist, Quality Control InstrumentationHolly Springs, NCPrior hands-on experience with analytical instrumentation associated with the following technologies: UPLC/HPLC, capillary electrophoresis/imaged capillary isoelectric focusing, gel electrophoresis/Western blot, plate readers, qPCR, spectrophotometry, and mass spectrometry. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place.
Senior Specialist 2, Quality Control Instrumentation FujifilmSenior Specialist 2, Quality Control InstrumentationHolly Springs, North CarolinaPrior hands-on experience with analytical instrumentation, including but not limited to UPLC/HPLC (Ultra/High-Performance Liquid Chromatography), Capillary Electrophoresis/Imaged Capillary Isoelectric Focusing (iCIEF), Gel Electrophoresis/Western Blot, Plate Readers, qPCR (Quantitative Polymerase Chain Reaction), Spectrophotometry, and Mass Spectrometry. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place.
Specialist, Quality Control Instrumentation FujifilmSpecialist, Quality Control InstrumentationHolly Springs, North CarolinaPrior hands-on experience with analytical instrumentation associated with the following technologies: UPLC/HPLC, capillary electrophoresis/imaged capillary isoelectric focusing, gel electrophoresis/Western blot, plate readers, qPCR, spectrophotometry, and mass spectrometry. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place.
Senior Manager, Quality Control Kyowa KirinSenior Manager, Quality ControlSanford, NCRemote$137,300–$185,000 / yearProvide technical leadership, collaborating cross-functionally in the site's early-stage activities, including: facility detailed design review; facility, equipment, and analytical instrument user requirements review; prioritization for implementation of equipment, instruments, and analytical methods required for facility start-up (GMP Ready/OQ Complete); and ICT efforts for developing user requirements and procuring selected electronic Quality Systems for operations (LIMS/ELN/Empower). Summary of Job: The Senior Manager, Quality Control will play a critical role in designing, developing, and executing the operational readiness program for the start-up of the Quality Control laboratories at the new Kyowa Kirin North America monoclonal antibody drug substance manufacturing facility in Sanford, NC.
Quality Control Microbiologist RD PartnersQuality Control MicrobiologistHolly Springs, North Carolina$41,600–$62,400R&D Partners is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. R&D Partners is a global functional service provider and strategic staffing resource specializing in scientific, clinical research & engineering.
Quality Control Analyst RD PartnersQuality Control AnalystHolly Springs, North Carolina$41,600–$62,400R&D Partners is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. R&D Partners is a global functional service provider and strategic staffing resource specializing in scientific, clinical research & engineering.
Administrator Salary Quality Control Wake County Public SchoolAdministrator Salary Quality ControlCary, NCExtensive knowledge with Oracle based testing and programming payroll processes; Considerable knowledge of the Department of Public Instruction (DPI) licensure and salary system; Considerable knowledge of the Budget Utilization Development (BUD) system; Considerable knowledge of Microsoft Office specifically Excel, Word Power Point; Google Apps; Working knowledge of database systems with the ability to analyze and organize data; Strong analytical and problem solving skills, attention to detail with a high level of accuracy; Effective time management skills with the ability to meet deadlines; Ability to communicate clearly and concisely both in oral and written form using a variety of communication techniques and tools to ensure the appropriate flow of information, collaborative efforts, and feedback; Ability to exercise independent initiative to perform both original and recurring assignments, and exercise judgment in the absence of clear directives; Ability to understand, interpret, and apply specific rules and regulations governing the processing of fiscal documents, maintenance of financial records, and the preparation of reports; Ability to communicate and maintain working relationships with school system employees, vendors, and other outside agencies. Bachelor's degree in accounting, finance, business administration, or directly related field; Two years of experience in payroll, bookkeeping, accounting, or related field; Other combinations of applicable education, training, and experience which provide the knowledge, skills, and abilities necessary to perform effectively in the position may be considered.
Administrator - Salary Quality Control Wake County Public School SystemAdministrator - Salary Quality ControlCary, North CarolinaFull timeExtensive knowledge with Oracle based testing and programming payroll processes; Considerable knowledge of the Department of Public Instruction (DPI) licensure and salary system; Considerable knowledge of the Budget Utilization Development (BUD) system; Considerable knowledge of Microsoft Office specifically Excel, Word Power Point; Google Apps; Working knowledge of database systems with the ability to analyze and organize data; Strong analytical and problem solving skills, attention to detail with a high level of accuracy; Effective time management skills with the ability to meet deadlines; Ability to communicate clearly and concisely both in oral and written form using a variety of communication techniques and tools to ensure the appropriate flow of information, collaborative efforts, and feedback; Ability to exercise independent initiative to perform both original and recurring assignments, and exercise judgment in the absence of clear directives; Ability to understand, interpret, and apply specific rules and regulations governing the processing of fiscal documents, maintenance of financial records, and the preparation of reports; Ability to communicate and maintain working relationships with school system employees, vendors, and other outside agencies. Bachelor’s degree in accounting, finance, business administration, or directly related field; Two years of experience in payroll, bookkeeping, accounting, or related field; Other combinations of applicable education, training, and experience which provide the knowledge, skills, and abilities necessary to perform effectively in the position may be considered.
Controls BAS System Specialist (Relocation assistance provided) MSS Solutions, LLCControls BAS System Specialist (Relocation assistance provided)Zebulon, NCWork Environment: Exposure to weather, extreme heat or cold, high noise intensity level, atmospheric conditions, exposure to electrical shock, exposure to toxic or caustic chemicals, wet and/or humid, vibration, proximity to moving mechanical parts, working high exposure places. Effectively documents work performed by completing necessary paperwork on each job to include: entering daily time, detailing scope of project progression, and maintaining an electronic database.
Document Controls Specialist DPS GroupDocument Controls SpecialistCary, NCThe Company DPS Group, Inc. is proudly part of the Arcadis Group of Companies and is a global EPCM firm offering full-service solutions within the Life Sciences (pharmaceutical, biotechnology, and medical technology) and Advanced Technology (semiconductor, data center, and solar) industries. DPS is dedicated to delivering successful projects with a client-first mentality and personal touch across a range of market sectors: Project and Program Management, Procurement, Design, Construction Management, Health and Safety Management, Commissioning, Qualification, and Start-up.
Project Controls Specialist - Michels Power, Inc. Michels CorporationProject Controls Specialist - Michels Power, Inc.Raleigh, North CarolinaWe execute the entire spectrum of electrical infrastructure projects—including the construction of transmission lines and substations, the modernization of distribution systems, and the development of both Oil & Gas facilities and Renewable Energy initiatives. Engineering News-Record ranks us the No. 1 Electrical Transmission/Distribution contractor in the U.S. We’re a national leader in substation and transmission construction with a long track record of success.
Quality Assurance Specialist II TalentBurst, Inc.Quality Assurance Specialist II20 TW Alexander Dr, Research Triangle Park,, NC$30–$32 / hourExamples of activities within the scope of oversight and auditing include but are not limited to: preclinical animal studies, sample analysis from clinical and preclinical studies, qualification and/or validation of methods, equipment/software validation, laboratory processes, etc. Education/ Qualifications: Quality Assurance Specialist - Bachelor's degree, in a health care or relevant scientific field and 3+ years of relevant industry experience.
Electrical Quality Specialist Adams Electric CompanyElectrical Quality SpecialistRaleigh, NCPerform all daily inspection and test of the scope and character necessary to achieve the quality of electrical construction required in the drawings and specifications for all works under the contract performed ON or OFF site. Requires familiarity in the use of computers and software packages needed to support the documentation, analysis and retention of quality records.
Document Control Specialist Thermo Fisher Scientific IncDocument Control SpecialistMorrisville, NCAs a Quality Specialist III, you will maintain regulatory compliance and drive continuous improvement of quality systems to support our mission of enabling customers to make the world healthier, cleaner, and safer. The Document Control Specialist is responsible for managing and optimizing document control processes within the MasterControl Quality Management System (QMS).
Control States Sales Specialist Republic National Distributing CoControl States Sales SpecialistRaleigh, NCThis role is responsible for selling products and services to a wide range of highly complex or major accounts and customers and/or a specific supplier, accountable for increasing sales/client ratio and expanding customer base. Demonstrate expertise knowledge of principles and methods for showing, promoting, and selling products or services that are considered specialized, fine wine, vintage, luxury, and/or specific to a designated supplier's portfolio of brands.
NewWarehouse Inventory Control & Logistics Specialist NovartisWarehouse Inventory Control & Logistics SpecialistDurham, North CarolinaData Analytics and Digital (Inactive), Good Manufacturing Practices (GMP), HSE Knowledge (Inactive), Inventory Management, Logistics and Transportation Management (Inactive), Master Data, Operational Excellence, Order Management, Resilience and Risk Management (Inactive), SAP Enterprise Resource Planning (ERP), Supply Chain Management (SCM), Supply Planning, Warehouse Management As a Warehouse Inventory Control and Logistics Specialist, you will play a pivotal role in ensuring seamless inventory management, data-driven decision-making, and regulatory compliance across warehouse and logistics activities.
Sr. Specialist, Quality Assurance LMS (Learning Management Systems) Kyowa KirinSr. Specialist, Quality Assurance LMS (Learning Management Systems)Sanford, NC$112,500–$131,000 / yearParticipate in continuous improvement of training processes and LMS workflows and provide subject matter expertise and leadership to establish a robust culture of quality based on patient-focus, sustainable compliance, and inspection-readiness for GxP training areas within the facility and laboratory areas. Kyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare disease.
Quality Specialist - 2nd Shift - RPO Eaton Corporation PlcQuality Specialist - 2nd Shift - RPORaleigh, NCAfter making a conditional offer and running a background check, if Eaton is concerned about conviction that is directly related to the job, you will be given the chance to explain the circumstances surrounding the conviction, provide mitigating evidence, or challenge the accuracy of the background report. In this function you will: Assist in quality audits, workmanship defect reduction efforts, corrective and preventive action identification, analysis and reporting, inspection of returned units, special inspections.
Specialist 2, Quality Assurance Technical FUJIFILM Biotechnologies USA IncSpecialist 2, Quality Assurance TechnicalNCServing as the QA point of contact for Warehouse, Supply Chain, and QC Raw Materials, this role resolves material-related issues and escalations, conducts quality impact assessments for investigations, change controls, and supplier change notifications, and ensures compliance with applicable procedures and data integrity requirements. Situated at the cross-section of Morrisville and Research Triangle Park (RTP), North Carolina, our site is at the heart of a booming biotech hub surrounded by top universities, vibrant communities, and various outdoor opportunities.
Medical Lab Specialist - Quality Management UNC HealthMedical Lab Specialist - Quality ManagementChapel Hill, NC$31.04–$44.62 / hourSummary: Provides technical expertise in specific laboratory discipline or program specialty, monitor and direct the workload and provides consultative and diagnostic results to clinicians. If, however, you are presently an employee of another North Carolina agency and currently participate in TSERS or the ORP, you will be eligible to continue participating in those plans at UNC Health.
Manufacturing QA Specialist Guerbet SAManufacturing QA SpecialistRaleigh, NCWhen you join Guerbet, you: Are choosing a global leader with recognized expertise in diagnostic and interventional imaging, Are joining our 2820 collaborators who are committed every day to offering innovative solutions to improve quality of patient's life all over the world, Are joining a company where we value diversity of talents coming from various horizon. Primary QA event response personnel that will respond to exceptions within the operations/packaging areas, having functions of initial exception impact assessment, product containment, bracketing, initial scope identification, and direction of immediate actions to take prior to resuming processing.
Manufacturing QA Specialist - 2nd shift Guerbet SAManufacturing QA Specialist - 2nd shiftRaleigh, NCWhen you join Guerbet, you: Are choosing a global leader with recognized expertise in diagnostic and interventional imaging, Are joining our 2820 collaborators who are committed every day to offering innovative solutions to improve quality of patient's life all over the world, Are joining a company where we value diversity of talents coming from various horizon. Primary QA event response personnel that will respond to exceptions within the operations/packaging areas, having functions of initial exception impact assessment, product containment, bracketing, initial scope identification, and direction of immediate actions to take prior to resuming processing.
Senior Specialist – Contamination Control and Investigations AmgenSenior Specialist – Contamination Control and InvestigationsHolly Springs, North CarolinaBasic Qualifications : Doctorate degree &2year ofdirectly relatedexperienceOrMaster'sdegree &4years ofdirectly relatedexperienceOrBachelor'sdegree &6years ofdirectly relatedexperienceOrAssociate'sdegree & 10 years ofdirectly relatedexperienceOrHigh school diploma / GED & 12 years ofdirectly relatedexperience. When completed, the AmgenFleXbatch facility will combine the latest in single use technologies with traditional stainless steel equipment to allow for maximum flexibility in operations TheFleXBatch facility will not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it will also integrate sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company by 2027.
Quality Assurance Specialist GlobalchannelmanagementQuality Assurance SpecialistMorrisville, North CarolinaCoordinate with cross-functional teams to ensure proper disposition of released or rejected materials, including timely transfer to designated storage or quarantine areas. Responsible for performing inspection and disposition of raw materials and components by: Supporting incoming material release activities within the ERP system, ensuring compliance with applicable regulations and internal procedures.
Senior QA Specialist, External Manufacturing, US Bavarian Nordic ASSenior QA Specialist, External Manufacturing, USDurham, NC$120,000–$155,000 / yearAs a global leader in smallpox and mpox vaccines, our growing portfolio includes market-leading vaccines against rabies, tick-borne encephalitis, cholera, typhoid, and Ebola. The ideal candidate will have deep expertise in aseptic GMP manufacturing environments, strong knowledge of sterile operations, and hands-on experience managing quality oversight of external manufacturing partners.
Specialist I, II, III Manufacturing Quality Systems SeqirusSpecialist I, II, III Manufacturing Quality SystemsHolly Springs, North CarolinaThe Manufacturing Quality Systems Specialist supports Fill Finish manufacturing operations by leading investigations, ensuring quality system execution, and providing technical expertise across multiple unit operations. With state-of-the-art production facilities in the U.S., the U.K. and Australia, CSL Seqirus utilizes egg, cell and adjuvant technologies to offer a broad portfolio of differentiated influenza vaccines in more than 20 countries around the world.
QA Specialist - Raw Materials KBI Biopharma IncQA Specialist - Raw MaterialsDurham, NCThe Specialist, Quality Assurance Raw Materials (QARM) is responsible for quality assurance activities associated with the sampling, review, qualification, and disposition of raw materials and consumables supporting both clinical and commercial biopharmaceutical manufacturing operations. This role provides quality oversight within a cGMP-regulated environment and supports supplier quality management, material release activities, investigations, change controls, and continuous quality improvement initiatives.
Quality Specialist III Precision BiosciencesQuality Specialist IIIDurham, NCRequired: Bachelor’s degree in Biology, Biochemistry, Chemistry, Microbiology, or a related life sciences discipline and 5+ years of relevant experience in a GMP-regulated environment, including background in quality assurance, research, or biopharmaceutical/gene therapy manufacturing, or equivalent combination of education and experience. The Quality Specialist III is responsible for providing dedicated quality assurance support for Chemistry, Manufacturing, and Controls (CMC) operations at Precision BioSciences, including batch release review, deviation assessment, and CDMO oversight.
Quality Assurance Specialist LancesoftQuality Assurance SpecialistResearch Triangle Park, NC$33Examples of activities within the scope of oversight and auditing include but are not limited to: preclinical animal studies, sample analysis from clinical (GCLP guidelines) and preclinical studies (GLP regulations), qualification and/or validation of methods, laboratory processes, etc. Education/ Qualifications: Quality Assurance Specialist - Bachelor’s degree, in health care or relevant scientific field and 3+ years of relevant industry experience.
Quality Specialist - cGMP Manufacturing - Weekend 1st Shift Alcami CorporationQuality Specialist - cGMP Manufacturing - Weekend 1st ShiftMorrisville, North CarolinaFull timeJob Summary: The Quality Specialist will provide site quality support in a fast-paced environment by effectively performing activities of substantial variety to ensure quality and compliance with applicable regulatory requirements and is proficient in all document and protocol approvals applicable to the respective processes executed at the respective lab or manufacturing facility. Activities include reviewing documents and data, supporting audits and inspections, consulting on quality and compliance issues, maintaining quality databases and performing trend analysis where needed, and performing quality and compliance training as needed.
Senior Specialist, Quality Engineer Kyowa KirinSenior Specialist, Quality EngineerSanford, NC$116,000–$152,300 / yearManager, Quality Systems & Compliance, this role helps implement and sustain Quality Engineering processes that enable GMP operations, regulatory compliance, audit defense, and compliant risk-based decision making across manufacturing-related systems. Summary: Kyowa Kirin is a Japanese-based company with a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare disease.
Supplier Quality Specialist Guerbet SASupplier Quality SpecialistRaleigh, NCWhen you join Guerbet, you: Are choosing a global leader with recognized expertise in diagnostic and interventional imaging, Are joining our 2820 collaborators who are committed every day to offering innovative solutions to improve quality of patient's life all over the world, Are joining a company where we value diversity of talents coming from various horizon. Provide ongoing quality oversight of suppliers supporting GMP manufacturing, including raw materials, consumables, external laboratories, and transportation providers.
Quality Specialist III Precision Biosciences IncQuality Specialist IIIDurham, NCRequired: Bachelors degree in Biology, Biochemistry, Chemistry, Microbiology, or a related life sciences discipline and 5+ years of relevant experience in a GMP-regulated environment, including background in quality assurance, research, or biopharmaceutical/gene therapy manufacturing, or equivalent combination of education and experience. The Quality Specialist III is responsible for providing dedicated quality assurance support for Chemistry, Manufacturing, and Controls (CMC) operations at Precision BioSciences, including batch release review, deviation assessment, and CDMO oversight.
Senior QA Specialist, External Manufacturing, US Bavarian NordicSenior QA Specialist, External Manufacturing, USDurham, North CarolinaRemoteAs a global leader in smallpox and mpox vaccines, our growing portfolio includes market-leading vaccines against rabies, tick-borne encephalitis, cholera, typhoid, and Ebola . The ideal candidate will have deep expertise in aseptic GMP manufacturing environments, strong knowledge of sterile operations, and hands-on experience managing quality oversight of external manufacturing partners.
QA Specialist - Raw Materials KBI BiopharmaQA Specialist - Raw MaterialsDurham, NCThe Specialist, Quality Assurance Raw Materials (QARM) is responsible for quality assurance activities associated with the sampling, review, qualification, and disposition of raw materials and consumables supporting both clinical and commercial biopharmaceutical manufacturing operations. This role provides quality oversight within a cGMP-regulated environment and supports supplier quality management, material release activities, investigations, change controls, and continuous quality improvement initiatives.
QA Area Specialist III - Finished Production (Validation Focus) Novo Nordisk ASQA Area Specialist III - Finished Production (Validation Focus)Clayton, NCDemonstrated expertise in Regulations & quality systems in one or more of the following: product disposition, DV/CAPA, Change Control, Audits, Supplier Management, Project Management, Validation, laboratory method and equipment validation, warehouse/logistics, and IT preferred. Quality oversight, review & approval of validation activities and documents associated with projects, new systems, changes to existing systems & maintaining validated state of equipment, processes, and systems.
Quality Assurance Area Specialist III Novo Nordisk ASQuality Assurance Area Specialist IIIClayton, NCDemonstrated expertise in Regulations & quality systems in one or more of the following: product disposition, DV/CAPA, Change Control, Audits, Supplier Management, Project Management, Validation, laboratory method and equipment validation, warehouse/logistics, and IT preferred. Our Product Supply Aseptic Manufacturing (PS AM) facility in Clayton, NC is a 457,000 square foot aseptic "fill and finish" site that is responsible for producing innovative, injectable diabetes and obesity treatments.
Quality Training Specialist Guerbet SAQuality Training SpecialistRaleigh, NCWhen you join Guerbet, you: Are choosing a global leader with recognized expertise in diagnostic and interventional imaging, Are joining our 2820 collaborators who are committed every day to offering innovative solutions to improve quality of patient's life all over the world, Are joining a company where we value diversity of talents coming from various horizon. This role partners with cross‑functional teams to drive training effectiveness, promote a culture of quality, and support continuous improvement through effective knowledge transfer and performance readiness.
Specialist 2, Quality Assurance Technical FujifilmSpecialist 2, Quality Assurance TechnicalResearch Triangle Park, North CarolinaServing as the QA point of contact for Warehouse, Supply Chain, and QC Raw Materials, this role resolves material-related issues and escalations, conducts quality impact assessments for investigations, change controls, and supplier change notifications, and ensures compliance with applicable procedures and data integrity requirements. Situated at the cross-section of Morrisville and Research Triangle Park (RTP), North Carolina, our site is at the heart of a booming biotech hub surrounded by top universities, vibrant communities, and various outdoor opportunities.
Sr. Quality Specialist Grifols SASr. Quality SpecialistNCManage the qualification and requalification of distributors, 3PLs, product and service providers, and transportation partners in accordance with regulatory requirements and Global Marketing decisions; ensure all (re)qualification records are maintained and archived per established procedures. The role manages key quality activities including audits, supplier and distributor qualification, change controls, risk assessments, KPIs, and quality system documentation to ensure ongoing regulatory compliance.