GMP QA Operations Specialist
6-month contract- Massachusetts, Boston
*Salary range between $60-65 /hour depending on experience*
Vertex's Quality Operational area is looking for a motivated GMP QA Operations Specialist. The ideal candidate will have experience with the batch release process, be able to work with cross functional teams, and have experience with the GMP document review process.
Education and Experience
- Bachelor's degree in scientific or allied health field (or equivalent degree).
- Typically requires a minimum of 5 years of experience, or the equivalent combination of education and experience.
- Experience providing Quality support of GMP manufacturing operations including batch release.
- Experience with small molecule (oral solid dosage forms preferred) development and manufacturing with proficient knowledge in a pharmaceutical setting.
- Knowledge of cGMP requirements governing small molecule manufacturing.
Knowledge and Skills:
- Experience supporting multiple projects/teams within stated objectives and timelines.
- Experience supporting cross-functional team members and collaborate effectively.
- Good communication skills (written and verbal) and the ability to exchange potentially complex information.
- Able to integrate activities with other groups, departments and project teams as needed.
- Demonstrated ability to perform evaluation of quality matters and solve straightforward problems using technical experience and judgement based on precedent and applicable SOPs.
- Demonstrated ability to evaluate internal and external excursions including deviations, investigations, CAPAs and change controls as well as performing Root Cause Analysis (RCA).
- Experience with batch record review and batch disposition activities for DS/DP.
- Ability to work in a fast-paced environment and meet quality, accuracy, and timeliness objectives.
- Expanded conceptual knowledge of cGMP's in a pharmaceutical setting.
- Proficient in leading event investigations, Root Cause Analysis (RCA), and CAPA
- Participates in cross-functional teams as a Quality technical resource responsible for providing support to manufacturing operations at contracted suppliers.
- Supports quality investigations /deviations and reviews corrective action plans for adequacy and compliance. This includes root cause analysis and product impact assessments for investigations resulting from deviations and OOS. Supports quality oversight for root-cause analysis and product impact assessment for investigations as a result of deviations, OOS, and OOT investigations ensuring appropriate CAPA actions are identified.
- Supports maintenance of Quality Metrics to support on time release deliverables.
- Supports drafting and revising Quality Agreements between CMOs/Suppliers and Vertex, as needed.
- Conducts GMP document review, including Master Batch Records, Executed Batch Records, Validation Protocols and Reports.
- Identify and communicate risks and assist with risk mitigation plans as necessary.