QC, Data Review Specialist II

Job DescriptionJob DescriptionQC Data Review SpecialistDEPARTMENT: QualityLOCATION: Durham, NC, Partially RemoteCOMPANY: Humacyte Inc (Nasdaq: HUMA) is developing a disruptive biotechnology platform to deliver universally implantable bioengineered human tissues, advanced tissue constructs, and organ systems designed to improve the lives of patients and...

Reviews, interprets, and analyzes data for technical, quality and compliance to protocols, methods, SOPs, client criteria and Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP). Performs review of the data for accuracy and compliance with reporting requirements prior to submission to QA and issuance to customers.Verifies that calculations...

Reviews, interprets, and analyzes data for technical, quality and compliance to protocols, methods, SOPs, client criteria and Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP). Performs review of the data for accuracy and compliance with reporting requirements prior to submission to QA and issuance to customers.Verifies that calculations...

Acts as Lead Data Reviewer for internal studies and works with Study Directors to ensure adequate and timely data review for all aspects of GLP and Preclinical Functionality studies including but not limited to medical records, surgical records, protocols, study dataResponsible for performing audits of protocol, SOP, and elements of the quality system to...

Acts as Lead Data Reviewer for internal studies and works with Study Directors to ensure adequate and timely data review for all aspects of GLP and Preclinical Functionality studies including but not limited to medical records, surgical records, protocols, study dataResponsible for performing audits of protocol, SOP, and elements of the quality system to...

Kelly Science has 2 urgent needs for QC Microbiologists in the Raleigh-Durham NC area. This is a 4 month contract with the potential to convert or extend. Shift: Monday-Friday 8am-5pm Hourly Pay Rate: $38-$45 Job Description Schedule and execute microbiological assays, including growth promotion of media, finished product sterility testing, and...

Job Title: Lead Data ReviewerLocation: Research Triangle Park NC 27709Duration: 12 monthsJob Description:Strong preference for GLP experience and willing to train data review aspect for the right candidate.Please focus on those with animal research background and GLP data review experience.Acts as Lead Data Reviewer for internal studies and works with Study...

Job Title: Lead Data ReviewerLocation: Research Triangle Park NC 27709Duration: 12 monthsJob Description:Strong preference for GLP experience and willing to train data review aspect for the right candidate.Please focus on those with animal research background and GLP data review experience.Acts as Lead Data Reviewer for internal studies and works with Study...

Job Title: Lead Data ReviewerLocation: Research Triangle Park NC 27709Duration: 12 monthsJob Description:Strong preference for GLP experience and willing to train data review aspect for the right candidate.Please focus on those with animal research background and GLP data review experience.Acts as Lead Data Reviewer for internal studies and works with Study...

Job Title: Lead Data ReviewerLocation: Research Triangle Park NC 27709Duration: 12 monthsJob Description:Strong preference for GLP experience and willing to train data review aspect for the right candidate.Please focus on those with animal research background and GLP data review experience.Acts as Lead Data Reviewer for internal studies and works with Study...

Support Laboratory Quality Systems including change control, investigations, deviations, events, SOP revisions, and documentation practices as part of the quality and compliance objectives.Conduct investigations related to quality systems such as deviations, events, NCRs, CAPAs, OOS, NOEs, complaints, and Quality Protocols of high complexity; works closely...

Support Laboratory Quality Systems including change control, investigations, deviations, events, SOP revisions, and documentation practices as part of the quality and compliance objectives.Conduct investigations related to quality systems such as deviations, events, NCRs, CAPAs, OOS, NOEs, complaints, and Quality Protocols of high complexity; works closely...

Piper Life Sciences is actively seeking a Quality Assurance Specialist to join a cell &gene therapy organization developing innovative AAV platform products for challenging diseases. The Quality Assurance Specialist will be responsible for the review and approval of data in a GMP environment. This is a Monday - Friday, traditional hours role that is...

Perform physical and chemical testing for topical formulations including but not limited to chromatography (GC and HPLC), particle size analysis, rheology, microscopy, and physical appearance.Ensure analytical testing of in-process, Drug Product (DP), stability samples and raw materials (API, excipients, and container closures) is performed according to GMP...

Perform physical and chemical testing for topical formulations including but not limited to chromatography (GC and HPLC), particle size analysis, rheology, microscopy, and physical appearance.Ensure analytical testing of in-process, Drug Product (DP), stability samples and raw materials (API, excipients, and container closures) is performed according to GMP...

Perform physical and chemical testing for topical formulations including but not limited to chromatography (GC and HPLC), particle size analysis, rheology, microscopy, and physical appearance.Ensure analytical testing of in-process, Drug Product (DP), stability samples and raw materials (API, excipients, and container closures) is performed according to GMP...

Description SDC is a team of diversified professionals who deliver exceptional Biometric Services, Consulting, and Technology Solutions to pharmaceutical, biologic, and medical device/diagnostic companies. Since 2005 our purpose has been to partner with sponsors to provide high-quality and experienced team members to develop great medicines that save...

Piper Companies is currently in search of a Quality Assurance Specialist to become a part of a cell and gene therapy organization that is pioneering advanced AAV platform products aimed at addressing complex diseases. The Quality Assurance Specialist will play a crucial role in the evaluation and endorsement of data within a GMP setting. This position...

Position Summary: The Quality Assurance (QA) Operations Sr. Specialist will be responsible for day-to-day support of GMP operations at the RTP CARsgen facility for clinical and commercial products. The team member will provide QA oversight of clinical trial drug production supporting raw material and product disposition. Additionally, this role is...

Position Summary: The Quality Assurance (QA) Operations Sr. Specialist will be responsible for day-to-day support of GMP operations at the RTP CARsgen facility for clinical and commercial products. The team member will provide QA oversight of clinical trial drug production supporting raw material and product disposition. Additionally, this role is...