Senior QA Specialist (cGMP – Pharmaceutical)

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.

Education:

Bachelors Degree in Science or related technical field.