Manager, Operational Quality - VCGT 897 (Contract)
Atrium Works•Boston, MA
•Onsite
About The Position
The Operational Quality Manager provides QA oversight for GMP manufacturing and testing operations. The role reviews batch records, deviations, in-process and environmental monitoring data, QC release and stability testing, and related quality documentation to support product disposition. This is a 12-month contract role, Monday through Friday, onsite. The posting describes it as a temporary position with a third-party agency partner, with overtime eligibility under applicable requirements. The pay range is $65–$75 per hour.
Requirements
- Bachelor’s degree in a scientific or allied health field and 5–7 years of relevant experience, or an equivalent combination of education and experience.
- Knowledge of current Good Manufacturing Practices (cGMP) in a pharmaceutical environment.
- Experience providing QA oversight for GMP manufacturing and testing operations.
- Experience reviewing GMP documentation from external vendors.
- Experience leading investigations, deviations, and change controls.
- Experience with systems such as Veeva, LIMS and Oracle.
- Strong attention to detail and effective written and verbal communication skills.
- Ability to manage competing priorities and timelines in a fast-paced environment.
Responsibilities
- Review master batch records and approve quality tasks for manufactured products.
- Review in-process, environmental monitoring, and QC data, including certificates of analysis, and provide required quality approvals.
- Perform final review of executed batch records and critical systems documentation, including certificates of analysis and conformance, in accordance with procedures.
- Confirm all required documentation is complete and acceptable before product or system release.
- Support investigations, deviations, and change controls within manufacturing operations.
- Support day-to-day management of the batch release process.
- Communicate proactively with internal and external partners and management.
- Maintain and archive records so documents are readily available and retrievable.
- Prepare metrics and data for program reporting.
- Escalate critical and major findings to Quality management.
- Collaborate with external vendors to review GMP documentation supporting product disposition.
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What This Job Offers
Career Level
Manager
