Job Description

At Microbial Manufacturing Services (MMS) a division of Thermo Fisher Scientific we deliver, from process development through commercial supply, the expertise and resources necessary to help clients deliver innovative therapeutics. Placed in the forefront of our leading- and cutting-edge Cell and Gene Therapy business enabling clients to cure genetic, rare, and otherwise untreatable diseases.

How will you make an impact?

The Quality Assurance Specialist will be the primary point of contact for the customer on all matters related Quality Assurance Operations. This position requires a highly motivated, tenacious, self-starter who can assimilate new information quickly and enjoys working closely with others within a fast-paced project execution environment. The individual will perform activities in support of dispositioning product and/or raw materials while ensuring compliance with VVS directives and procedures, customer requirements, and regulatory standards.

What will you do?

Responsible for contributing to key functional, tactical, and operational aspects of VVS operations at the Cambridge site. This includes approval & oversight of MFG and QC activities associated with CAPA, deviations, and other documentation related to MFG and QA operations. Additional responsibilities may include support in personnel interviewing/training, compliance with policies & inspections. Provides feedback for personnel development.

Daily check in with operations, quality on the floor for critical operations
Records review (e.g. Batch Record/Logbook review/PM/CAL review)
Document/Label Issuance and archival
Quality documentation support for Critical MFG Operations on the floor
Participate in Investigations, CAPA, and Change Control. Approval of quality documents through the electronic system (TrackWise)
Identify process improvement initiatives, procedure generation and compliance
Draft quality procedures as directed by supervisor or manger
Review and approve documents including: Standard Operating Procedures, Batch Records, Work Instructions.
Perform environmental data review and release production areas post change over
EM Data review for Room release
Support third party audits, external customers, and Agency inspections as needed and support internal activities concerning any identified nonconformities
Manage projects assigned. Able to multi-task efficiently to ensure timely project completion.

This position is a M-F 8am-5pm role. Flexibility and overtime may be required on holidays and weekends to support project timelines.

How will you get here?

Education
BS in Regulatory & Compliance, Biological Science or related technical field
2 years of minimum experience in a related Quality position supporting the manufacture and testing of biologics, medical device, or pharmaceutical products in cGMP environment.

Experience
Advanced knowledge of U.S. and EU regulations, related ICH guideline and industry standards.