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QC, Data Review Specialist II
2 months ago
- 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 and documentation was performed per ALCOA+ principles.
- Verifies that all analyses are performed per methodology and are in compliance with GMP requirements, when applicable.
- Understands testing protocols and other reference materials such as USP-NF and European Pharmacopoeia.
- Detailed review for multiple projects in a concurrent and timely manner on a routine basis.
- Interact with Quality Assurance on routine basis on the data submitted and corrections if any.
- Discuss the questions or potential discrepancies in laboratory documentation and audit trails with the supervisors and analysts, work toward resolution prior to escalation, where possible.
- Elevate and investigate if necessary to determine the impact on the data or data system.
- Assist R&D with technical review of method validations/verifications/method transfers, protocols, data and reports.
- Participate in Lab deviations, investigation and Audits if necessary
- Demonstrate professionalism to coworkers, customers and an understanding of quality in a regulatory industry.
- Able to react to change productively and handle other essential tasks as assigned.
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QC Data Review Specialist
2 months ago
Durham, United States HUMACYTE GLOBAL INC Full timeJob 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...
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QC, Data Review Specialist II
1 month ago
Durham, United States MedPharm (formerly Tergus Pharma) Full timeReviews, 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...
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QC, Data Review Specialist II
4 days ago
durham, United States MedPharm (formerly Tergus Pharma) Full timeReviews, 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...
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QC Data Reviewer
4 weeks ago
Durham, United States Indotronix Avani Group Full timeActs 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...
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QC Data Reviewer
4 weeks ago
Durham, United States Indotronix Avani Group Full timeActs 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...
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QC Microbiologist II
1 week ago
Durham, United States Kelly Services Full timeKelly 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...
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Data Reviewer
4 weeks ago
Durham, United States Indotronix International Corporation Full timeJob 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...
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Data Reviewer
4 days ago
durham, United States Indotronix International Corporation Full timeJob 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...
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Data Reviewer
4 days ago
durham, United States Indotronix International Corporation Full timeJob 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...
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Data Reviewer
4 weeks ago
Durham, United States Indotronix International Corporation Full timeJob 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...
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QC Technical Writer
4 days ago
durham, United States MedPharm (formerly Tergus Pharma) Full timeSupport 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...
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QC Technical Writer
4 days ago
durham, United States MedPharm (formerly Tergus Pharma) Full timeSupport 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...
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Quality Assurance Specialist, Cell
4 weeks ago
Durham, United States Piper Companies Full timePiper 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...
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Chemist II
4 days ago
durham, United States MedPharm (formerly Tergus Pharma) Full timePerform 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...
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Chemist II
2 months ago
Durham, United States MedPharm Ltd Full timePerform 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...
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Chemist II
2 months ago
Durham, United States MedPharm Ltd (formerly Tergus Pharma) Full timePerform 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...
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Principal Biostatistician
3 months ago
Durham, United States SDC (Statistics & Data Corporation) Full timeDescription 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...
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Quality Control Specialist in Gene Therapy
4 days ago
Durham, North Carolina, United States Piper Companies Full timePiper 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...
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Senior QA Operations Specialist
1 month ago
Durham, United States CARsgen Therapeutics Full timePosition 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...
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Senior QA Operations Specialist
1 month ago
Durham, United States CARsgen Therapeutics Full timePosition 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...