Bio-Manufacturing Compliance Specialist
Framingham, MA 01701
Pay Rate: $30/hour to start
Company Description: A global biopharmaceutical company committed to healthcare solutions from prevention to treatment. We turn scientific discoveries into medicine to improve human health. Everyday we dedicate our most important resource, our people, to support patients and families through their health journey.
This position will report to the Quality Supervisor / Manager and will assist in maintaining the quality systems and GMP compliance in support of ongoing operations at the Biosurgery manufacturing site.
Compliance Specialist duties will include but not be limited to:
Perform all aspects of lot issuance, lot review/release process, ensuring compliance to the relevant site release SOP and corporate standard.
Perform review of testing results in support of release of release of intermediates.
Perform QA presence on the floor (oversight or AQL, as appropriate).
- Ensure compliance to the relevant SOP and corporate standards.
Ensure that documentation and operations meet established requirements of cGMPs, Internal SOPs and company policies.
Strong technical background in regulated products.
Excellent communication skills both written and verbal.
Strong critical thinking ability.
Effective time management and organizational skills.
- Strong attention to detail and ability to work with others in a group environment
- Special Working Conditions: Ability to gown and enter clean rooms
Bachelor's Degree & 3 years' of experience OR
Associate's Degree & 5 years of experience in Quality or cGMP operations.