The QA Specialist will be primarily responsible for Key Quality Systems such as CAPAs/Deviations, Test Data Analysis/Certificates, Trend Analysis, Complaint Handling, Internal Quality Auditing, and GMP Training. Activities include managing, data review and analysis for these systems.
- The position manages the Deviation and CAPA systems for all excursions generated during GMP activities, and works with responsible parties to ensure timely completion.
- This position manages Certificates for all GMP testing, including release and stability assays, and all calibration and validation activities.
- This position manages all GMP training activities and all records associated with that activity. This includes ensuring all training records are complete for all employees involved in GMP activities to ensure compliance with CGMP regulations and internal procedures.
- In addition, the position supports various other QA activities which include document review and approval of Executed Batch Records, Specifications for API, raw materials, finished products and labeling, validation protocols and reports. The position also conducts and maintains internal audits, and performs trend analysis for various Quality Systems.
- Critical responsibilities of this position are the timely Quality Assurance data review and data generation to support drug development, issuance of certificates of analysis as pertains to client sponsored testing, disposition for release of products intended for toxicology studies, clinical trials and commercial market.
- This position is responsible for inventory activities, such as receipt and inspection of raw materials, components and drug products, and performing monthly inventory to ensure expired raw materials are removed from inventory. This also includes receiving and processing drug products for client specific testing, packaging and shipping of drug products per CGMP requirements, and programming and downloading data from log tags to monitor temperature during shipment of temperature sensitive materials.
- The responsibilities of this position may be expanded to meet evolving Quality and Compliance needs, provided adequate training for these responsibilities is documented.
- Bachelor’s degree and a minimum of 2 years related experience in Quality Assurance and/or cGMP is preferred