Specialist, Quality Assurance
2 weeks ago
Specialist, Quality Assurance
6 Month Initial Contract
Norwood, MA | Onsite
Max PR: $50 per hour
Immediate Need for an Internal Quality Assurance Specialist in Norwood Massachusetts
MUST HAVE's
- Willing to to work 100% on-site in Norwood, MA
- 2-4 years of experience in quality oversight or manufacturing experience in early stage clinical products
- Experience executing the review of batch records & GMP manufacturing experience
- Will be conducting Batch Record reviews both paper & electronic for QA
- Quality Systems experience (SAP & Veeva) is a plus
- Degree Required (BS or MS)
SUMMARY
The individual in this role will be part of a cohesive team responsible for supporting cGMP mRNA drug products produced internally. He/she will provide quality oversight and expertise to enable technical success with stringent adherence to a Quality System that respects global regulatory expectations. The successful candidate will have experience in quality oversight or manufacturing experience in early stage clinical products. They will be able to interact fluidly with peers and supervisors in Manufacturing, and cross-functionally with Quality Control, Manufacturing, Logistical and Process Development Technology Transfer counterparts.
RESPONSIBILITIES
- Conduct thorough review of Master Batch Records (MBR) and electronic Batch Records (eBR), collaborating closely with the manufacturing team to ensure timely finalization of documentation.
- Perform quality inspections of logbooks that are pending review to ensure compliance and completeness.
- Provide quality supervision during the implementation of corrective actions and preventive actions (CAPA) and verify the effectiveness of these actions to sustain production continuity or advance processes to subsequent phases.
- Oversee the resolution of quality documentation, including deviations, change controls, CAPAs, Process Improvements (PI), and Engineering Changes (EC), prioritizing collaboration with interdisciplinary teams to expedite the completion of these records, addressing them in order of receipt or as per the backlog.
- Review and certify scanned copies of GMP documents submitted for archive.
- Additional duties as may be assigned as needed
Education & Qualifications
- 2-4 years of experience in a GMP Manufacturing environment
- Bachelor’s degree in a science related field
- A desire to make an impact as part of a high-growth, transformational company
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