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:

Bachelor’s Degree in Science or related technical field.