li>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. Akarsh Yathiraj| Senior Recruiter |
| C. | (415) 322-5419 |
| D. | (415) 322-5419 |
| A. | 611Research Triangle Park, North Carolina22 days ago 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. Must be able to effectively collaborate cross-functionally with peers, scientific and technical staff; and be comfortable working in a matrixed team. 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. 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. Holly Springs, NC17 days ago 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. 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.
- Provide ongoing quality oversight of suppliers supporting GMP manufacturing, including raw materials, consumables, external laboratories, and transportation providers.
Raleigh, North Carolina6 days ago p style="font-size:11pt;line-height:116%;margin:0pt">Abrigo is seeking an IT Assurance Specialist to join our IT Risk & Assurance Team, assisting with recurring IT internal control testing, third-party risk management activities, and audit and compliance operations for a fintech SaaS company serving community financial institutions nationwide. What You’ll Need: - Degree in Information Systems, Cybersecurity, Accounting, Computer Science, Business Administration, or related discipline; equivalent professional experience or relevant internships may be considered in lieu of a degree.
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. li>Technical: Experience or familiarity with Quality Management Systems (e.g., Veeva, TrackWise) Demonstrated experience across key quality assurance functions in a GMP setting (e.g., batch record review, batch release functions, GxP document archival, as applicable). The QA Specialist, EMQO supports Quality Assurance activities at the Eisai Raleigh facility by assisting with routine operational quality tasks under direction and supervision. Durham, North Carolina30+ days ago 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. For additional information on Company employee benefits programs, visit https://careers.eisai.com/us/en/compensation-and-benefits. E-Verify is an Internet based system operated by the Department of Homeland Security in partnership with the Social Security Administration that allows participating employers to electronically verify the employment eligibility of all new hires in the United States. 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. 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. 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). p>The QA Specialist II, Quality Operations is responsible for quality operation activities related to clinical and commercial drug products in adherence with current Good Manufacturing Practices (cGMP) and corporate policies and procedures at the RTP campus. Perform quality assurance functions, including inspection of production equipment for cleanliness, gowning, area line clearances, in-process packaging checks, AQL inspections and floor audits, in support of manufacturing and packaging activities. 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: Durham, North Carolina21 days ago 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: 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.
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. 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, 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 If any information I have provided is untrue, or if I have concealed material information, I understand that this will constitute cause for the denial of employment or immediate dismissal.. All vaccinated employees are required to provide proof of their COVID-19 vaccination, with a COVID-19 vaccination which has been granted FDA approval or Emergency Use Authorization.. Morrisville, North Carolina14 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. 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. Morrisville, North Carolina22 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. 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. 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.
After 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.
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. Durham, North Carolina27 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. Work At Home-North Carolina, NC20 days ago 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. 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. Requirements: • Sound knowledge of core design methods (sketching, wireframing, storyboarding, etc.) • Ability to describe success metrics for design contribution and show a passion for evaluating design solutions with qualitative and quantitative analysis • Ability to design in various contexts, contributing to long-term strategic projects, last-minute fixes, and short-term solutions - sometimes without all the information present to make comfortable design decisions • Demonstrated ability to communicate sound design rationale through different mediums and design deliverables • Experience designing content, creating applications and working with complicated back-end constraints • Experience using design and prototyping tools like Figma • Thrive working in a fast-paced, startup type environment with a bias towards finding solutions vs. Preferred Qualifications: • Bachelors degree or equivalent experience in graphic design, industrial design, human computer interaction, architecture, multidisciplinary design, user experience, psychology, English, computer science, or a related field. Research Triangle Park, NC30+ days ago Project Lifecycle & Migration Management: Lead the end-to-end commissions system migration by maintaining master project plans, tracking dependencies, and managing the "source of truth" for all project artifacts and documentation. Business Alignment & Strategy: Partner closely with business stakeholders to gain a deep understanding of sales compensation plans and incentive structures, ensuring technical implementations align with evolving sales strategies. |