Overview
The QA Supervisor will report directly to the QA Manager or Quality Director.
This position is responsible to actively participate in the Repligen ISO 9001 Quality Management System. This role is responsible for the oversight of all daily QA inspection activities, of finished products and sub-assemblies.
Responsibilities
- Manage daily schedules and on time final product release.
- Manage, train, and develop QA inspection team.
- Plan and implement QA inspection resources to support quality related activities.
- Performs in-process finished goods and final inspection including visual inspection.
- Review and approve LHR for final QA release in SAP.
- Must be proficient in Good Documentation Practices (GDP), understanding of deviation investigations, nonconformances, and generate corrective actions to improve processes/systems.
- Initiate NCMRs for non-conforming materials and assist in investigations.
- Work closely alongside Manufacturing to identify and resolve product quality issues.
- Represent QA product release during Tier II and Tier III meetings.
- Track and trend QA data and generate KPIs.
- Assist with Nonconformance investigations, deviations, and corrective actions.
- Assist in Customer complaints investigations.
- Develop processes to improve efficiency.
Qualifications
- BS/BA or bachelor’s degree with 5 years of experience or Associate's Degree with 7 years of experience in QA/QC area.
- Quality Management Systems experience.
- Strong understanding of ISO 9001, ISO 14644 and or CFR 820 Regulation.
- Experience using electronic Quality system software (CaneaOne)
- Able to lead a group and work independently, without instruction.
- Knowledge of inspection techniques and various sampling plans
- Ability to contribute to and lead project teams.
- Experienced with investigation tools and statistical analysis, e.g. Minitab, SAS etc.
- Experience leading Quality audits both internally and externally, shares timely information with peers on progress.
- Excellent cross-functional team participation skills
- Highly organized and detail oriented.
- Proficient in written and oral presentations skills. Proficient with word processing, presentations, spreadsheets, internet software, manufacturing software, database software
What Repligen Offers
Our mission is to inspire advances in bioprocessing as a trusted partner in the production of biologic drugs that improve human health worldwide. Focused on cost and process efficiencies, we deliver innovative technologies and solutions that help set new standards in bioprocessing. The estimated base salary range for this role, based in the United States of America is $85,000-110,000. Compensation decisions are dependent on several factors including, but not limited to an individual's qualifications, location, internal equity, and alignment with market data. Additionally, employees are eligible to participate in one of our variable cash programs (bonus or commission) and eligible roles may receive equity as part of the compensation package. We offer a wide range of benefits such as paid time off, health/dental/vision, retirement benefits and flexible spending accounts. All compensation and benefits information will be confirmed in writing at the time of offer.
