The Sr. QA Specialist is directly responsible for site QA activities; supporting Medical Device and Pharmaceutical product platforms, including final approval on all cGMP documents. The Sr. QA Specialist is responsible for several key systems in support of ISO requirements; site nonconformance investigations and associated CAPA, risk assessment, document control and product release/disposition in coordination with the QRT Team. The Sr. QA Specialist works independently and collectively as part of an integrated team environment with extensive interactions with Manufacturing, Maintenance, and Administrative departments. The Sr. QA Specialist is also responsible for tracking training and reporting to management on the compliance status of the site. The Sr. QA Specialist will report directly to the General Manager.
- QA: Authorized as the final approver for batch release, validation, and QMS System documentation, QMS Management Representative for ISO 9001 and ISO 13485; interacting with auditors, including the FDA. Maintains quality service by enforcing organization standards and providing guidance to site. Actively supports the quality and business requirements of the EMS and Quality Systems.
- Regulatory: Participates in communication with customers and prospective customers on product implementation and regulatory notifications related to product quality. Maintains site compliance requirements for FDA and other relevant agencies. Responsible for oversight of Pharmacovigilance System.
- Validation: Represents Quality for engineering and validation programs by reviewing and approving validation documents.
- Purchasing: Uses the purchasing system to procure supplies.
- DCR System: Directly responsible for the DCR System to change or add new document requirements; coaching personnel. Assigned as a DCR Coordinator in the writing and revision of documents.
- CIMP System: Directly responsible for the continuous improvement and Kaizen events and projects.
- NCR System: Directly responsible for the nonconformance system through investigation and reporting of Nonconformances for the site. Provides reports and communication based on investigation findings.
- Training: Directly responsible for training system oversight. Provides reports to managers in support of continued competency. Monitors employee progress and competency to promote continued employee growth.
- BS/MS in science major or extensive equivalent experience, 10+ years’ experience in a pharmaceutical, medical device, or related facility.
- Experience in ISO standard execution.
- Required reading, writing, and speaking fluently in English and preparing reports.