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Senior QA Specialist (cGMP - Pharmaceutical)

AM Technical Solutions, Inc

AM Technical Solutions, Inc

Quality Assurance
Posted on Thursday, January 26, 2023

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.