We are looking for a proven Quality resource to join our Life Sciences team in support of a pharmaceutical client in the Boston, MA area. Ideal candidates should have a strong understanding of GMPs and have previous experience working within highly regulated pharmaceutical/biotech facilities.
The QA Specialist will support the delivery of quality system activities at the Manufacturing Facility to ensure commercial and/or clinical products are manufactured and distributed in accordance with all regulatory and corporate requirements.
Roles and Responsibilities:
- Responsible for being a quality contact and primary Subject Matter Expert (SME) for complex deviations for systems, processes and equipment related to engineering, facilities, automation, manufacturing, and validation.
- Support and review complex deviation investigations related to manufacturing process equipment, utilities, automation, validation, and engineering.
- Act as an advisor and make recommendation to Quality Assurance Management for the release of equipment based on completion of corrective actions related to a complex deviation.
- Work closely with Operations, Facilities, Manufacturing, Automation, Validation, and Engineering to resolve open issues resulting from equipment failures, issues, and deviation record reviews.
- Lead the QA review and assessments of deviations; includes performing risk assessments, leading root cause analysis investigations, tracking, follow-up, close out, and reporting/trending.
- Review and approve Corrective and Preventative Actions (CAPA); includes tracking, follow-up, reporting/trending, and evaluating CAPA for effectiveness.
- Lead identification and implementation of improvement opportunities for issues related to automation issues, equipment, and validation failures.
- Proficient in entering information from deviations into TrackWise (or similar Quality system) and generating reports from these systems.
- QA review and approval of engineering drawings/documentation, specifications, system assessments, validation protocols, and validation summary reports.
Position Requirements and Qualifications:
- 5+ years’ of GMP-related experience in biopharmaceutical or pharmaceutical manufacturing facilities.
- Thorough knowledge of cGMP/GDP and international regulatory requirements.
- Operations experience in a GMP environment.
- Knowledge of Six Sigma methodologies (e.g. Lean, 5S, Kaizen) and Critical Thinking methodologies (e.g. Kepner-Tregoe) is strongly preferred.
- Ability to prioritize daily activities in order to meet internal and external customer needs in a fast-paced environment.
- Ability to work on Quality projects where analysis of data requires evaluation of identifiable factors.
Bachelor’s Degree in Science or related technical field.