Senior QA Specialist – Plant Operations
RoslinCT US•Hopkinton, MA
•$77,000 - $115,000
About The Position
The Senior QA Specialist – Plant Operations is responsible to provide QA support and expertise to manufacturing plant operations. This includes supporting QA specific procedures related to product disposition, line clearance and review and approval of GMP documentation including but not limited to Batch Records, Quality records, and Calibration/Work Order Records. The ideal candidate has worked in a start up environment with internal manufacturing operations.
Requirements
- 5-8 years of relevant Quality Assurance experience in a pharma/biotech company with internal manufacturing.
- Prior experience in Quality Assurance Operations focused on support of internal manufacturing operations.
- Ability to partner cross functionally and provide quality support within agreed timelines to support plant start up activities
- Ability to work independently to meet objectives and timelines
- Ability to resolve issues and make decisions of moderate complexity independently and escalate complex decisions as needed.
- Well versed in cGMP and ICH regulations / guidelines
- Strong verbal and written communication skills
Nice To Haves
- Cell therapy experience preferred.
- Prior experience working in contract services and interfacing with clients preferred
Responsibilities
- Support day-to-day operations, including batch record review and review of QC testing records to ensure compliance with approved procedures.
- Support product disposition
- Assist in deviation investigations, CAPA and Change Control implementations.
- Develop training materials and deliver training for QA specific procedures
- Monitor implementation of QA specific procedures for compliance and identify opportunities for improvement
- Work cross functionally and provide QA support for development, review and approval of procedures/workflows for manufacturing operations
- Provide QA review and approval of plant related SOPs and GMP documentation
- Mentor personnel within QA and cross functionally on GMP compliance, promote quality culture
- Other duties as assigned.
Benefits
- medical, dental, and vision insurance
- educational assistance
- a 401(k) program
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Education Level
No Education Listed
