841 Results for

Quality Specialist Jobs in Chapel Hill, NC

Jobs

Research Triangle Park, NC30+ days ago

$0–$33 Per Hour

Examples 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. Since our formation in 2002, organizations across commercial and public sectors have been trusting us to help build their teams with exceptional temporary and permanent talent.

Raleigh, NC17 days ago

$40–$55 Per Hour
Contractor
Full-time

The Communications Consultant – Account Managers are responsible for managing the development and execution of all communications projects for customer work to ensure message and brand consistency and align with corporate strategies. Work with key clients and the External Digital Communications Channels team to improve the company’s online marketing channels and ensure processes are followed.

New!

Chapel Hill, NC5 days ago

$31.04–$44.62 Per Hour

The Specialist works in collaboration with the laboratory supervisor and laboratory directors to address analytical problems and maintain scientific oversight of routine patient testing.

The Microbiology Laboratory is currently recruiting a Medical Laboratory Specialist for the Central Processing, Bacteriology, and Special Microbiology areas of the laboratory.

New!

Raleigh, NC4 days ago

$33.04–$47.50 Per Hour

Operates multichannel physiologic monitor to measure and record functions of cardiovascular and pulmonary systems of patient during cardiac catherization.

Learn more about the incentive program here: https://jobs.unchealthcare.org/pages/imaging-commitment-incentive-program.

New!

Durham, NC6 days ago

These areas include: Student Advisor, Malnutrition Specialist, Adult Nutrition Support Specialist, Pediatric Nutrition Support Specialist, Program Coordinator, Clinical and Quality Specialist, IT Specialist, Outpatient Clinical Coordinator, Lead, Subject Matter Expert.

Coordinate all phases of nutrition care including nutrition assessment, care planning, monitoring, education and counseling of hospitalized patients and outpatients in a variety of settings.

Durham, NC30+ days ago

We are Looking For: • Bachelor's degree or higher in Life Sciences, Chemistry, Engineering, or related field • Minimum of 8 years of pharmaceutical industry experience, working in Supplier Quality role, and/or Quality/Compliance • Experience in biotechnology industry preferred • Strong knowledge of cGMP in the Pharma/Biotech industry to include FDA, EU, JP regulatory requirements as well as ICH/ISO guidelines • Knowledge of aseptic and sterile product manufacturing processes and testing • Experience in Vendor Quality Oversight • Thorough knowledge of and competence in core quality processes such as change control, deviations/OOS, CAPA, and complaints. In this role, you will be responsible for providing quality oversight of suppliers and vendors supporting the manufacture, packaging, testing, and distribution of clinical and commercial gene and cell therapy products at OXB, playing a key part in advancing our mission and making a real difference.

Durham, NC30+ days ago

$113,000–$156,000 Per Year

Provides QA oversight of analytical and microbial laboratory activities including but not limited to method qualification, method transfers, method validations, creation and revision of test methods, specifications, stability studies, laboratory investigations and laboratory deviations. The Principal QA Specialist provides exemplary service to both internal and external customers by ensuring patient safety and regulatory compliance while supporting product lifecycle activities for timely delivery of products to clients for patients.

Work At Home, NC10 days ago

$18.50–$42.35 Per Hour

Our teams reflect the customers, patients, members and communities we serve and we are committed to fostering a workplace where every colleague feels valued and that they belong. Quality Specialist- Medicare D Quality role administers the quality management system to manage the review of clinical processes, documentation, and patient records.

Holly Springs, NC12 days ago

$94,000–$174,600 Per Year

You will partner directly with the QC department to provide day-to-day quality compliance support, serving as a trusted gatekeeper for data integrity, support investigations and manage change controls related to laboratory systems, test methods, and digital applications, ensuring modifications do not compromise the validated state of our operations.

This position is a unique opportunity to embed quality into the site's operational design, support a continuous improvement culture, and drive operational excellence in accordance with Good Manufacturing Practices, establishing Holly Springs as a center of excellence for aseptic drug product manufacturing.

Durham, North Carolina30+ days ago

Durham, North Carolina22 days ago

p style="margin:0px">Avance Care is seeking an experienced Advanced Practice Provider (Nurse Practitioner or Physician Assistant) for an exciting opportunity to grow your career in a role that offers both meaningful patient connection and broader organizational impact.

If you’re looking for a role where you can care for patients, influence meaningful change, and grow as a clinical leader, we invite you to join Avance Care and be part of the future of high-quality, data-driven healthcare.

Durham, NC30+ days ago

Remote

$120,000–$155,000 Per Year

As 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.

New!

Durham, NC6 days ago

p>Required:

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.

Durham, NC30+ days ago

p>Job Responsibilities:

Works directly with Manufacturing, QA and other departments responsible for GMP activities to resolve production related deviations and other compliance issues in a timely manner.
Minimum Requirements:
- Minimum BS in scientific field with 14+ years' experience or MS and 11+ years' experience in a QA cGMP regulated environment within Biopharmaceuticals or equivalent.

Morrisville, North Carolina30+ days ago

p style="margin:0px">At Alcami, we deliver reliable solutions that unlock the potential of transformative medicines from discovery to commercialization, through trusted partnership with our clients, recognized industry expertise and proven regulatory track record. Job Summary:

The Senior Quality Assurance Specialist is accountable for driving results in a fast-paced environment by effectively performing activities as directed to ensure quality and compliance with applicable regulatory requirements and internal procedures.

Sanford, NC30+ days ago

Monitor and analyze site quality metrics-including Deviations, CAPAs, Change Controls, Equipment Failures, EM data trends, and Product Disposition Cycle-times to identify trends, support continuous improvement, and ensure compliance. 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.

New!

Durham, NC2 days ago

Required: 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.

Durham, North Carolina30+ days ago

p/>

Job Responsibilities:

Works directly with Manufacturing, QA and other departments responsible for GMP activities to resolve production related deviations and other compliance issues in a timely manner.
Minimum Requirements:
- Minimum BS in scientific field with 14+ years’ experience or MS and 11+ years’ experience in a QA cGMP regulated environment within Biopharmaceuticals or equivalent.

Durham, NC30+ days ago

p>Demonstrated solid Body of Knowledge of Quality systems and functions supporting drug or related FDA governed manufacturing obtained from professional Quality roles Includes a balance of, from such areas as Supplier Quality Assurance, Compliance, Audits/Inspections, Shop Floor Support, Batch / Material release, Quality document control, review and approval, Validation, QC, Deviations, Prior direct regulatory agency, and audit management /r support experience a plus.

Ability to work effectively with others and communicate in customer-facing forums to progress issues and obtain positive results Able to navigate conflict to achieve deliverables and drive to targeted outcomes Ability to work professionally and facilitate positive interdepartmental interactions with a diverse group of people Voluntarily communicates needs and suggestions clearly and effectively Listens and is attentive to others' ideas and contributions.

NC14 days ago

Example: If a job level requires a Bachelor's degree plus 4 years of experience, an equivalency could include 8 years of experience, an Associate's degree with 6 years of experience, or a Master's degree with 2 years of experience.

Third Party Agency and Recruiter Notice:

Agencies that present a candidate to Grifols must have an active, nonexpired, Grifols Agency Master Services Agreement with the Grifols Talent Acquisition Department.

Holly Springs, NC30+ days ago

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. If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department (FDBN_PNC@fujifilm.com).

Holly Springs, NC21 days ago

Provides QA oversight and supports DSM operations in accordance with governing processes and procedures• Provides QA support of DSM tasks such as o Batch Record and Solution Lot Record review, including exception-based oversight using Quality Review Management tool o Real time event triage and implementation of immediate response to identified deviations o Area changeover and return to service o Real time WO oversight per applicable procedures• Ensures department objectives are met within desired timelines and/or in accordance with identified KPIs• Contribute to the development of QA documentation, procedures, and processes for operational readiness objectives and QA support of manufacturing operations in cGMP regulated facility• Participate in streamlining or efficiency improvement initiatives with other FUJIFILM Diosynth Biotechnologies sites. Minimum Requirements: BS/BA in Life Sciences or Engineering or equivalent with 2+ years of relevant experience OR• Masters in Life Sciences or Engineering or equivalent with 0 years' relevant experience• 1-3 years' experience in a GMP environment• Experience in Validation, cGMP manufacturing operations and/or Quality oversight, in an FDA regulated facility.

Work At Home-North Carolina, NC15 days ago

$18.50–$38.82 Per Hour

Acts as an advocate and subject matter expert guiding the business by serving as a quality champion through measuring and monitoring the quality and effectiveness of work processes in claim processing and customer service that impact customer satisfaction, medical cost management, and operational efficiency. Acts as a subject matter expert on Quality Specialist workflows, policies, systems requirements, and enhancements as well as daily operations and programs to consistently drive optimal results.

Raleigh, NC16 days ago

When 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. Working cross-functionally with Quality, Operations, and other stakeholders, the Specialist ensures quality systems are robust, compliant, and effectively embedded across the organization.

Durham, NC30+ days ago

$55,000–$86,900 Per Year

This includes performance of compliance review of records (master batch records, executed batch records, and internal support records such as logbooks), aid in deviation determination/generation, general Quality guidance. In addition to supporting Manufacturing, MQA Specialists are responsible for the execution of core activities, including but not limited to:

Executed Batch record review and approval.

Durham, NC30+ days ago

$140,000–$185,000 Per Year

Beams suite of gene editing technologies is anchored by base editing, a proprietary technology that is designed to enable precise, predictable and efficient single base changes, at targeted genomic sequences, without making double-stranded breaks in the DNA. The role will provide Quality oversight of routine manufacturing, testing, and related operations to ensure that systems and processes are maintained in compliance with Good Manufacturing Practices (GMP), and ultimately to Good Distribution Practices (GDP) as the programs move to the commercial phase.

Mebane, North Carolina24 days ago

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Minimum 5 years relevant work experience in Incoterms knowledge, customer experience success, project execution, and supply chain, OR Associate degree in Engineering or related field PLUS minimum 7 years relevant work experience OR High School Diploma/GED PLUS 9 years of relevant work experience.

In this role, you will have the opportunity to support the deployment of the quality strategy for a local organizational unit, including quality culture, systems, tools, and competent teams with the aim to achieve and exceed customer expectations, while ensuring sustainable operations.

Raleigh, NC19 days ago

Responsibilities include: preparing and providing technical quality control for environmental documents and permit applications developing and executing dispersion modeling approaches and protocols preparing emissions inventories, health risk evaluations (as applicable), and compliance analyses mentoring staff and coordinating and reviewing technical work across project phases developing task scopes, budgets, and schedules, and supporting proposal and marketing efforts when requested helping project managers to integrate air quality strategy into broader project planning and environmental compliance frameworks, including beginning to advise project teams and clients on regulatory interpretation and risk considerations and serving as a technical resource where appropriate in client and agency interactions. A senior-level environmental planner at Anchor QEA can expect: Strategic, impact-focused role, shaping project approaches and outcomes Highly supportive environment as part of multi-disciplinary, collaborative teams Opportunities for client and agency interaction, helping to guide key decision makers Contribution to business development strategies emphasizing valued relationships Strong emphasis on professional development for technical and leadership growth Culture of flexibility and accountability with an emphasis on work-life balance.

Durham, North Carolina30+ days ago

Includes a balance of, from such areas as Supplier Quality Assurance, Compliance, Audits/Inspections, Shop Floor Support, Batch / Material release, Quality document control, review and approval, Validation, QC, Deviations, Prior direct regulatory agency, and audit management /r support experience a plus.

Minimum 5 years prior experience in the Pharmaceutical/Biotechnology industry with a thorough knowledge of Quality Systems, Quality Assurance and Quality Control including solid knowledge of global GMP Quality and Regulatory requirements.

Durham, North Carolina30+ days ago

Executed Batch record review and approval.

Morrisville, North Carolina30+ days ago

Job 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.

Raleigh, NC9 days ago

Remote

$22–$25 Per Hour

p>Eurofins Environment Testing (USA) provides a compensation range for informational purposes, the actual base compensation may vary based upon, but not limited to, relevant experience and skill set, base compensation of internal peers, business sector, and geographic location. With climate change posing an imminent threat, Eurofins and its many companies recognize their duty to proactively reduce or offset the environmental impact of essential operations while also helping our clients do the same-serving as a true ESG Enabler.

Research Triangle Park, NC30+ days ago

The role plays a critical part in ensuring sustained compliance with current Good Manufacturing Practices (cGMP), FDA regulations, and Grifols Quality Systems by proactively analyzing, interpreting, and monitoring quality data, key metrics, and associated systems. Ability to successfully interface with all levels of management and customers or suppliers in various functions to ensure well documented, factually supported analyses of issues related to supplier, test lab, warehouse logistics and plasma platform quality.

New!

NC6 days ago

p>Summary:

Ensures current Good Manufacturing Practices (cGMP) and FDA/Grifols Quality Systems through the participation in management, analysis and monitoring of quality data and metrics and associated quality systems.

Third Party Agency and Recruiter Notice:

Agencies that present a candidate to Grifols must have an active, nonexpired, Grifols Agency Master Services Agreement with the Grifols Talent Acquisition Department.

Sanford, NC30+ days ago

$76,200–$104,800 Per Year

Monitor and report key performance indicators (KPIs) for Site Quality Metrics, including deviations, CAPAs, change controls, OOS, invalid assays, OOT, equipment failures, EM data trends, stability trends, and product disposition cycle times. 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.

Durham, NC30+ days ago

OXB collaborates with some of the world's most innovative pharmaceutical and biotechnology companies, providing viral vector development and manufacturing expertise in lentivirus, adeno-associated virus (AAV) and adenoviral vectors. In this role, you will be responsible for overseeing all Facilities operations within an FDA-approved clinical cGMP manufacturing facility, playing a key part in advancing our mission and making a real difference.

Research Triangle Park, NC30+ days ago

$33–$33 Per Hour

(415) 322-5419

611

Durham, GA30+ days ago

$72,000–$82,000 Per Year

You will lead utilization review activities, apply evidence-based criteria to clinical cases, and partner cross-functionally to strengthen the quality and appropriateness of care across SonderMinds platform. We want the experience of working at SonderMind to accelerate peoples careers and enrich their lives, so we focus on meeting SonderMinders wherever they are and supporting them in all facets of their lives and work.

Holly Springs, NC17 days ago

$45–$55 Per Hour

Operating within the QC Systems group and reporting to the Manager of Digital Laboratory Systems, this role partners closely with QC subject matter experts to analyze workflows, identify inefficiencies, and build scalable digital solutions that enhance data accessibility, reporting, and operational efficiency. Doctorate degree and 2 years of experience, or Master's degree and 6 years of experience, or Bachelor's degree and 8 years of experience, or Associate degree and 10 years of experience, or high school diploma / GED and 12 years of experience.

20 TW Alexander Dr, Research Triangle Park,, NC30+ days ago

$30–$32 Per Hour

Quality Assurance Specialist - Bachelor's degree, in a health care or relevant scientific field and 3+ years of relevant industry experience.

Raleigh, NC30+ days ago

As the world's only end-to-end professional services firm focused on MedTech, we take clients' Vision to Velocity through our comprehensive service portfolio, with expertise in human centered design and product development, preclinical and clinical research, regulatory affairs, and market access and reimbursement consulting. What You Will Do: Perform day‑to‑day maintenance and administration of the QMS, including eQMS data entry, document updates, records management, monitoring system due dates, and responding to quality‑related requests from staff and project teams.

Durham, NC30+ days ago

li>Works directly with manufacturing, facilities, and other departments responsible for GMP activities to support resolution of deviations and other compliance issues in a timely manner in support of batch release activities.

Job Responsibilities:

Works directly with Manufacturing, QA and other departments responsible for GMP activities to resolve production related deviations and other compliance issues in a timely manner.

Morrisville, North Carolina9 days ago

Morrisville, North Carolina30+ days ago

Morrisville, North Carolina17 days ago

Holly Springs, NC8 days ago

$33–$50 Per Hour

li>Author, revise, and review documents and reports, including SOPs, test methods, safety assessments, trend reports, qualification/validation summary reports, and technical reports. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing winner for both client and talent service.

Raleigh, NC30+ days ago

li>Perform 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.

Durham, NC30+ days ago

MQA Senior Specialist: BS/BA degree in scientific field and 8 years experience or MS/MA degree and 6 years' experience in a QA GMP regulated environment within Biopharmaceuticals or equivalent is required. This position will be responsible for on the floor review of executed records (batch record section review, solution records, equipment records, and logbooks) supporting all aspects of cGMP operations.

Durham, NC30+ days ago

This position will be responsible for on the floor review of executed records (batch record section review, solution records, equipment records, and logbooks) supporting all aspects of cGMP operations. MQA Specialist II: BS/BA in scientific field and 5 years experience or MS/MA degree and 3 years' experience in a QA GMP regulated environment within Biopharmaceuticals or equivalent is required.

Durham, NC30+ days ago

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Quality Specialist Jobs in Chapel Hill, NC

Quality Assurance Specialist II DivIHN Integration Inc

Communication Specialist IV - (Account Manager & Creative Project Manager) # 26-13303 US Tech Solutions

Medical Lab Specialist - Microbiology Laboratory UNC Health

Cardiovascular Specialist - Rex Invasive Heart & Vascular UNC Health

Clinical Dietitian - Outpatient Pediatric Duke Health

Senior Specialist, Quality Assurance, Compliance and Supplier Quality Oxford BioMedica Plc

KBI: US - Principal QA Specialist KBI Biopharma Inc

Quality Specialist - Medicare D Quality CVS Health Corp

Senior QA Specialist, QA for QC (CVRM) Genentech Inc

KBI: US - Principal QA Specialist KBI Biopharma

Advanced Practice Provider (NP/PA) - Clinical Quality Specialist I Avance Care

Senior QA Specialist, External Manufacturing, US Bavarian Nordic AS

Quality Specialist III Precision Biosciences Inc

Senior QA Specialist Deviations and CAPAs KBI Biopharma Inc

Sr. Quality Specialist - cGMP Manufacturing - Weekend 1st Shift Alcami Corporation

QA Specialist II - Operations Kyowa Kirin Pharmaceutical Research Inc

Quality Specialist III Precision Biosciences

Senior QA Specialist Deviations and CAPAs KBI Biopharma

Principal QA Specialist KBI Biopharma Inc

Clinical QA Systems and Documentation Specialist Grifols SA

QA Specialist, Warehouse (Supply Chain) FUJIFILM Biotechnologies USA Inc

QA Specialist, DSM (0600 1800/2 2 3) FUJIFILM Biotechnologies USA Inc

Senior Quality Specialist CVS Health Corp

Quality Systems Improvement Specialist Guerbet SA

KBI: US - QA Specialist II KBI Biopharma Inc

Sr. Specialist I, Product Quality Assurance Beam Therapeutics Inc

Customer Quality Specialist ABB

Senior Air Quality Specialist Anchor QEA LLC

Principal QA Specialist KBI Biopharma

KBI: US - QA Specialist II KBI Biopharma

Quality Specialist - cGMP Manufacturing - Weekend 1st Shift Alcami Corporation

Quality Administrative Specialist, Eurofins Built Environment Testing, Remote Eurofins Scientific SE

Quality Risk Specialist Grifols SA

Quality Analytics Specialist Grifols SA

Specialist II, Quality Control - Microbiology Kyowa Kirin Pharmaceutical Research Inc

Senior Specialist, Quality Assurance Oxford BioMedica Plc

Quality Assurance Specialist II Leadstack Inc

Clinical Quality Specialist SonderMind Inc

Quality Control Senior Specialist Actalent Inc

Quality Assurance Specialist II TalentBurst, Inc.

Quality Assurance Specialist 2 Veranex Inc

Principal Quality Compliance Specialist Deviations and Client Support KBI Biopharma Inc

Sr. Quality Assurance Specialist - 3rd Shift Alcami Corporation

Sr. Quality Assurance Specialist Alcami Corporation

Sr. Quality Assurance Specialist - 2nd Shift Alcami Corporation

Specialist Quality Control Actalent Inc

Electrical Quality Specialist Adams Electric Company

QA Manufacturing Specialist II/Senior (Day Shift) KBI Biopharma Inc

QA Manufacturing Specialist II KBI Biopharma Inc

QA Manufacturing Specialist II/Senior (night shift) KBI Biopharma Inc

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