Quality Assurance Operations Specialist
2 days ago
At CARsgen Therapeutics, we are seeking a highly skilled Quality Assurance Operations Specialist to join our team. This role will be responsible for providing day-to-day support of GMP operations at our RTP facility, ensuring the quality and integrity of our clinical and commercial products.
Key Responsibilities:- Provide QA oversight of clinical trial drug production, including raw material and product disposition.
- Support department deliverables/metrics, investigations/deviations, Change Controls, and CAPA's associated with products/process occurring at the site.
- Interact cross-functionally with Manufacturing, Regulatory, Quality Control, Supply Chain, and Technical Operations teams.
- Oversee line and production room line clearances, label issuance and reconciliation, and ensure aseptic techniques and good cleaning room behaviors are followed.
- Support the deviation investigations and ensure on-time closure of the deviations.
- Provide QA support for QC activities, including the review of QC testing records, SOPs, and reports.
- Support QA activities for Supply Chain, including the review of incoming materials, SOPs, and reports.
- Create, revise, and implement quality assurance standard operation procedures and work instructions for the site when necessary.
- Conduct data analysis to support tracking of Key Quality Performance Indicators and generate quality metrics monthly reports.
- Support internal and external audits and continuous improvement efforts regarding Operations as it relates to Quality Management processes.
- 6+ years of experience in the clinical and/or commercial pharmaceutical/biopharmaceutical industry.
- Good knowledge of biologics cGMP manufacturing, including cell therapy and aseptic processing.
- Strong interpersonal skills and ability to work collaboratively across functions.
- Growth-oriented with a continuous improvement mindset and passionate about working in GMP environments.
- Ability to communicate in a proactive and solution-focused manner, including keeping management aware of potential issues.
-
Quality Assurance Operations Specialist
3 weeks ago
Durham, North Carolina, United States CARsgen Therapeutics Full timeJob SummaryThe Quality Assurance Operations Specialist will be responsible for day-to-day support of Good Manufacturing Practice (GMP) operations at CARsgen Therapeutics' facility for clinical and commercial products.Key ResponsibilitiesQA Operations Support: Provide on-the-floor QA support for GMP operations, including in-process batch record review, QA...
-
Quality Assurance Specialist
3 weeks ago
Durham, North Carolina, United States Lilly Full timeJob Title: Quality Assurance SpecialistWe're seeking a highly skilled Quality Assurance Specialist to join our team at Lilly. As a key member of our Quality Assurance team, you will play a critical role in ensuring the quality and safety of our products.Job Summary:The Quality Assurance Specialist will be responsible for reviewing batch records, performing...
-
Quality Assurance Specialist
4 weeks ago
Durham, North Carolina, United States Carolina Components Group Full timeJob SummaryJob Title: Quality Assurance SpecialistJob Type: Full-timeLocation: Durham, NCJob Summary: The Quality Assurance Specialist is responsible for ensuring process, material, and assembly compliance to customer specifications, regulatory requirements, and company standards. The individual is responsible for understanding and effectively operating...
-
Quality Assurance Specialist
2 weeks ago
Durham, North Carolina, United States Lilly Full timeAbout LillyLilly is a global healthcare leader that discovers, develops, and delivers medicines that help people live longer, healthier, and more active lives. We are committed to making a difference for people around the world by delivering innovative medicines and solutions that meet real needs.Job SummaryWe are seeking a Quality Assurance Specialist to...
-
Quality Assurance Specialist
3 weeks ago
Durham, North Carolina, United States AISIN North Carolina Corporation Full timeAbout the RoleAISIN North Carolina Corporation is seeking a highly skilled Quality Assurance Specialist to join our team. As a key member of our Supply Chain Quality team, you will be responsible for ensuring the quality of supplied parts and materials.Key ResponsibilitiesQuality Control and Assurance: Conduct regular audits and inspections to ensure...
-
Manufacturing Quality Assurance Specialist
4 weeks ago
Durham, North Carolina, United States Fujifilm Corporation Full timeAbout the RoleFujifilm Diosynth Biotechnologies is a leading Contract Development and Manufacturing Organization (CDMO) that partners with clients to deliver innovative solutions for the biopharmaceutical industry. We are seeking a highly motivated Senior QA Technical Specialist to join our team in Research Triangle Park, NC.Key ResponsibilitiesFunction as...
-
Senior Quality Assurance Specialist
3 weeks ago
Durham, North Carolina, United States Humacyte Global, Inc. Full timeSenior Quality Assurance SpecialistHumacyte Global, Inc. is a leading biotechnology company developing innovative solutions for tissue repair and replacement. We are seeking a highly skilled Senior Quality Assurance Specialist to join our Quality Assurance Team.Key Responsibilities:Design and implement comprehensive Product Technical Complaints (PTC) and...
-
Quality Assurance Specialist
2 days ago
Durham, North Carolina, United States Lilly Full timeWe're seeking a highly skilled Quality Assurance Specialist to join our team at Lilly. As a key member of our Quality Assurance team, you will play a critical role in ensuring the quality and safety of our pharmaceutical and medical device products.Key Responsibilities:Review and approve batch records for parenteral manufacture, semi-finished devices, and...
-
Quality Assurance Specialist
1 week ago
Durham, North Carolina, United States MILLENNIUMSOFT Full timeJob Title: Quality Laboratory Systems SpecialistJob Summary:We are seeking a highly skilled Quality Laboratory Systems Specialist to join our team at MillenniumSoft. The successful candidate will be responsible for supporting the development, implementation, and maintenance of our Quality Systems, ensuring compliance with regulatory requirements and industry...
-
Quality Assurance Specialist III
4 weeks ago
Durham, North Carolina, United States HUMACYTE GLOBAL INC Full timeJob SummaryThe Quality Assurance Specialist III provides critical support to the overall Quality Assurance program at Humacyte Global Inc. Ensuring manufacturing operations are in compliance with cGMP and GTP regulations and local procedures is a key responsibility.Key ResponsibilitiesLead and provide oversight to operations on the shop floor, supporting...
-
Senior Quality Assurance Specialist
1 week ago
Durham, North Carolina, United States KBI BioPharma Full timeJob SummaryWe are seeking a highly skilled Senior Quality Assurance Specialist to join our team at KBI Biopharma. This role will be responsible for ensuring the quality and compliance of our manufacturing operations, collaborating with cross-functional teams to resolve production-related deviations and other compliance issues, and providing training and...
-
Quality Assurance Specialist
3 weeks ago
Durham, North Carolina, United States BioSpace, Inc. Full timeAbout the OpportunityWe are seeking a highly motivated and detail-oriented Quality Assurance Intern to join our team at Novo Nordisk. As a Quality Assurance Intern, you will have the opportunity to gain hands-on experience in quality management processes, with a focus on document control and records management.Key ResponsibilitiesConduct research, gather,...
-
Head of Quality Assurance
2 weeks ago
Durham, North Carolina, United States BiotechPharma Full timeJob Title: Head of QualityThe Head of Quality at our Biotech/Pharma company is a critical role responsible for overseeing the Quality Assurance and Quality Control functions. This position requires a strong leader who can manage a team of QA & QC Specialists, ensure compliance with regulatory requirements, and drive process improvements.Key...
-
Senior Quality Assurance Specialist
2 days ago
Durham, North Carolina, United States KBI BioPharma Full timeJob SummaryThis Quality Assurance Specialist position collaborates with cross-functional teams to ensure compliance with cGMP requirements and company SOPs. The role is responsible for reviewing and approving Deviations, CAPAs, and Effectiveness Checks, as well as providing support for timely review of events for classification, initiation in EtQ, and...
-
Senior Quality Assurance Auditor
3 days ago
Durham, North Carolina, United States Proclinical Staffing Full timeSenior Auditor for Quality AssuranceProclinical Staffing is currently recruiting for a dedicated Senior Auditor for Quality Assurance to join a Contract Research Organization (CRO). This role focuses on maintaining and enhancing quality initiatives within the company, including Standard Operating Procedures (SOPs) and training, computer systems validation,...
-
Quality Assurance Technical Lead
4 weeks ago
Durham, North Carolina, United States Fujifilm Corporation Full timeAbout the RoleFujifilm Diosynth Biotechnologies is a leading Contract Development and Manufacturing Organization (CDMO) that partners with clients to deliver innovative solutions for the biopharmaceutical industry. We are seeking a highly motivated Senior QA Technical Specialist to join our team in Research Triangle Park, NC.Key ResponsibilitiesFunction as...
-
Quality Assurance Specialist
5 days ago
Durham, North Carolina, United States Carolina Components Group Full timeQuality Inspector Job DescriptionThe Quality Inspector is a critical role within the Carolina Components Group, responsible for ensuring that all processes, materials, and assemblies meet customer specifications, ISO 9001, cGMP, and company standards.Key Responsibilities:Process and inspect incoming materials, labeling, and release for inventory...
-
Senior Quality Assurance Specialist
3 weeks ago
Durham, North Carolina, United States KBI BioPharma Full timeJob SummaryWe are seeking a highly skilled Quality Assurance Specialist to join our team at KBI Biopharma. The successful candidate will be responsible for ensuring the quality and compliance of our products, collaborating with cross-functional teams, and mentoring junior QA staff.Key ResponsibilitiesCollaborate with Manufacturing, QA, and other departments...
-
Quality Assurance Specialist
6 days ago
Durham, North Carolina, United States Carolina Components Group Full timeJob SummaryCarolina Components Group is seeking a highly skilled Quality Inspector to join our team. As a Quality Inspector, you will be responsible for ensuring process, material, and assembly compliance to customer specifications, ISO 9001, cGMP, and company standards.Key ResponsibilitiesAccurately and completely process assigned Orders through the Quality...
-
Quality Assurance Specialist
6 days ago
Durham, North Carolina, United States Carolina Components Group Full timeQuality Inspector Job DescriptionThe Quality Inspector is a critical role within the Carolina Components Group, responsible for ensuring that all processes, materials, and assemblies meet customer specifications, ISO 9001, cGMP, and company standards.Key Responsibilities:Process and inspect assigned orders through the Quality Department prior to shipment to...