| Sr. QA Specialist :: Essex County, MA :: Onsite at Essex, Massachusetts, USA |
| Email: [email protected] |
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https://jobs.nvoids.com/job_details.jsp?id=1983407&uid= From: Santosh, Vyzeinc [email protected] Reply to: [email protected] Job Description - Job Title: Sr. QA Specialist - (Biotechnology) Location: Essex County, MA Duration: 6 Months+ Need a very strong candidate pv will take 30 min screening call directly with the candidate Need LinkedIn A Pharmaceutical client is looking for a Senior Quality Assurance Specialist , specifically with CMO batch compliance experience in biotechnology or pharmaceutical industry Job Overview The Senior Associate will be a key member of QA team in the assessment of CMO batch compliance with FDA and ICH regulations as well as internal procedures. This person will also be responsible for deviation and investigation review and closure and data entry. In addition, there will be periodic tasks such as SOP and policy revisioning as part of continuous improvement initiatives Job Functions: (Primary essential duties and responsibilities) Actively participates as a member of the Quality Assurance Ops Team and partners with the technical and analytical team. Support Manufacturing and Testing Operations during CMO batch production, ensuring unexpected events are handled compliantly and in a timely manner. Review and approve documents including: CMO Manufacturing batch records, lot disposition documentation/systems, Certificates of Analysis, deviations, investigations and OOS in support of product release Required Knowledge, Skills and Abilities: -Experience in cGMP Environment - Strong knowledge of FDA, EU, ATMP and JP regulations -Cell and Gene Therapy Keywords: quality analyst Massachusetts Sr. QA Specialist :: Essex County, MA :: Onsite [email protected] https://jobs.nvoids.com/job_details.jsp?id=1983407&uid= |
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| 09:27 PM 04-Dec-24 |