Quality Assurance Manager

Focus Laboratories
  • Cherry Hill Township, NJ
  • Full-time
  • Instant Apply
30+ days ago

Job Description

Who We AreTPM Laboratories, Inc. is an independent contract testing laboratory providing personalized analytical services to the pharmaceutical and chemical industries. TPM Labs specializes in Analytical Research and Development Testing Services, Quality Control Testing and Stability Storage & Testing Services.Our goal is to provide high quality, cost effective and timely service, personalized to meet your needs.Scope of the RoleThe QA Manager leads TPM Laboratories’ quality system and ensures laboratory work meets cGMP, FDA, ICH, USP, and internal requirements. This role exists to protect data integrity, keep the site inspection-ready, and provide clear QA governance across documentation, investigations, and releases.Key responsibilities include leading QA staff; maintaining QA policies, SOPs, and controlled documents; approving methods, specifications, and validation protocols; reviewing analytical data for accuracy and compliance; overseeing OOS/OOT, deviations, CAPA, and change control; trending quality events; managing internal audits; supporting client and regulatory audits; and driving GMP training and continuous improvement.Required qualifications/skills:- Bachelor’s in Chemistry (or related discipline)- 6–8 years in a regulated pharmaceutical/laboratory environment- Strong QA systems, audit, and compliance oversight experience- Proven review/approval of scientific and regulatory documentation- People leadership experience; strong knowledge of ALCOA+ and 21 CFR 210/211Apply if you can set direction, make sound quality decisions, and lead a compliant, audit-ready lab.Your Typical DayYou start by checking the status of open quality events and the lab’s inspection-readiness items, then confirm priorities with senior leadership. Mid-morning is focused time for document review—data packages, controlled records, and technical reports—so releases and client timelines stay on track.As the day moves on, you shift between short, agenda-led team touchpoints and deeper problem-solving sessions where you align QA expectations with operational realities. You may host or prepare for a client audit, review responses and commitments, or brief teams on a regulatory update.Before the day ends, you look ahead: confirm resources and schedules, ensure projects are logged correctly in Pryme, and identify one practical improvement to strengthen compliance without slowing delivery. 

Numbers & Facts

LocationCherry Hill Township, NJ
Job TypeFull-time

Skills

  • Analysis Skillsunmatched
  • Analytical Developmentunmatched
  • Auditingunmatched
  • Biotech and Pharmaceuticalunmatched
  • Change Controlunmatched
  • Chemistryunmatched
  • Code of Federal Regulationsunmatched
  • Continuous Improvementunmatched
  • Corrective and Preventative Action (CAPA) Systemsunmatched
  • Current Good Manufacturing Practice (cGMP)unmatched
  • Customer Support/Serviceunmatched
  • Data Qualityunmatched
  • Documentationunmatched
  • Documentation Reviewunmatched
  • FDA (Food and Drug Administration)unmatched
  • GMP (Good Manufacturing Practices)unmatched
  • ICH Regulationsunmatched
  • Information/Data Security (InfoSec)unmatched
  • Internal Auditunmatched
  • Laboratoryunmatched
  • Laboratory Analysisunmatched
  • Leadershipunmatched
  • Maintain Complianceunmatched
  • Problem Solving Skillsunmatched
  • Project Scheduleunmatched
  • Quality Assuranceunmatched
  • Quality Controlunmatched
  • Quality Managementunmatched
  • Regulationsunmatched
  • Research & Development (R&D)unmatched
  • Scientific Publicationsunmatched
  • Team Lead/Managerunmatched
  • Test Labunmatched
  • Test Plan/Scheduleunmatched
  • Testingunmatched
  • Time Managementunmatched
  • Validation Planunmatched

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