| #Urgent Role For Quality Assurance Manager Cambridge, MA (Onsite) at Cambridge, Massachusetts, USA |
| Email: [email protected] |
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http://bit.ly/4ey8w48 https://jobs.nvoids.com/job_details.jsp?id=2096372&uid= From: Akash Kumar, Sonitalent Corp [email protected] Reply to: [email protected] Hi Hope you are doing well, We are looking for Quality Assurance Manager Please let me know if you are looking for this role and send me your updated resume also. Job Title: Quality Assurance Manager Location: Cambridge, MA (Onsite) (Local) Duration of project: 12 months Required visa: Any visa (Except H1B and CPT) Note: Please include two prior work references with work email and work phone number. I will be checking. MUST HAVE: 6+ years of experience in cGMP Quality Assurance in Biologics or Cell & Gene Therapy product manufacturing Issue, review, and approve GMP documentation (e.g., batch records, SOPs, job aids, etc.) needed for internal manufacturing operations. Review labeling and packaging batch records and prepare documentation for release. Responsibilities: Issue, review, and approve GMP documentation (e.g., batch records, SOPs, job aids, etc.) needed for internal manufacturing operations. Review logbooks and reconcile documentation. Assist with walkthroughs with senior Quality staff members. Review labeling and packaging batch records and prepare documentation for release. Review work orders, equipment qualification, and validation documentation for adequacy and compliance. Review batch record documentation, ensure compliance and accuracy, and prepare for drug substance/product and/or critical material release. Engage in daily onsite quality oversight and guidance and collaborate across functions, leveraging quality and manufacturing expertise to provide guidance on non-conformance/deviations, troubleshoot/problem solve, interpret data, and apply a risk-based approach for ongoing manufacturing operations and related quality events. Represent QA in onsite operations from the thaw of starting material to drug substance/product filling and labeling. Additional duties as assigned. Requirements: Masters Degree in Microbiology, Biology, Chemistry or a related field Working knowledge of cell or gene therapy product testing, manufacturing, or development 5+ years of experience in cGMP Quality Assurance in Biologics or Cell & Gene Therapy product manufacturing Demonstrated knowledge of current GMP regulations associated with pharmaceuticals, cell therapies, gene therapies, etc. in the field of responsibility. Understanding and working knowledge of Quality Management System expectations, ability to interpret requirements, anticipate issues, make informed decisions, and respond rapidly to emerging quality situations. in the field of responsibility. Local travel between manufacturing sites required. Thanks & Regards -- Akash Kumar Technical Recruiter, Sonitalent Corp Direct:8596593266 || https://www.linkedin.com/in/akash-kumar-151a8025a/ [email protected] Website: https://www.sonitalentcorp.com/ 5404 Merribrook Lane, Prospect, KY, USA . | | Keywords: quality analyst Kentucky Massachusetts #Urgent Role For Quality Assurance Manager Cambridge, MA (Onsite) [email protected] http://bit.ly/4ey8w48 https://jobs.nvoids.com/job_details.jsp?id=2096372&uid= |
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| 04:57 AM 21-Jan-25 |