Quality Assurance Specialist; QAS

Job Description | Quality Assurance Specialist (QAS) I

Title | Quality Assurance Specialist I

Department | Quality & Compliance

Reports To | Regional Manager, Quality Assurance (or equivalent QA Manager)

Compensation | $30-$33/hr

The Quality Assurance Specialist I will be responsible for the oversight of the Quality Assurance program and the Quality Management System at the site level.

• Maintain oversight of the QA program and Quality Management System (QMS) at a single SOFIE manufacturing facility producing products under both 21 CFR Part 212 and 211 (as needed) regulations.
• Apply quality assurance processes and procedures at the site level to ensure product quality and regulatory compliance.
• Strong collaboration, including problem solving and continuous improvement efforts, and communication with the Facility Manager and Operations team.
• Write, review, approve, and implement procedures, specifications, processes, and methods as required.
• Oversee the examination and evaluation of each lot of incoming material before use to ensure that the material meets its established specifications.
• Ensure that components, containers, closures, in-process materials, packaging materials, labeling, and finished dosage forms are examined and approved or rejected to ensure that all these meet their current specifications.
• Ensure that personnel are properly trained and qualified. Ensure the training is documented.
• Conduct periodic audits of the site to monitor compliance with established procedures and practices. May infrequently audit another site.
• Liaise with internal and external inspectors and representatives, particularly on QA-related topics.
• Oversee the metrology program at the site (i.e., equipment, personnel qualifications, validations, etc.).
• Ensure manufacturing and analytical equipment is appropriately maintained and calibrated. Ensure applicable facility certifications are maintained. Identify to management problems in personnel, equipment, and the facility that require correction.
• Review documents associated with the site’s QA program for completeness, errors, and omissions.
• Review executed CGMP records and product batch records to ensure compliance and product quality.
• Review trends (e.g., environmental monitoring, deviations, facility issues, etc.) to initiate corrective and preventive actions and/or for continuous process improvement.
• Conduct continuous review of aseptic operations to ensure compliance to internal procedures (e.g., gowning, cleaning, sanitation, sterility, environmental monitoring, etc.) and USP/FDA regulations.
• Ensure any deviations from normal procedures are documented and justified.
• Ensure an investigation is performed and documented when required, and corrective and preventative actions are taken (i.e., follow and maintain corporate CAPA, deviation, and OOS protocols).
• Ensure compliance to all applicable standard operating procedures and regulations, including 21 CFR Part 212 (and 211 as needed) requirements.
• Ensure product complaints are managed in a manner consistent with Company SOPs and FDA regulations.
• Responsible for opening change controls and initiating, maintaining, and reviewing SOFIE network and site-specific procedures relative to their job functions.
• Oversee the site-level change control process. Ensure that changes in the laboratory are accepted or rejected as appropriate, and ensure the changes are appropriately documented.
• Attend quality and operational meetings. Interface with Corporate QA and Operations on quality related issues. Provide status updates as required management.
• Expected extensive knowledge of at least one SOFIE product.
• Other responsibilities as required.

• Bachelor’s Degree (Scientific / Medical / Quality), at minimum, preferred.
• Experience and/or full knowledge of manufacturing operations, preparation of sterile injectables, aseptic processing, and distribution of aseptic products preferred.
• Quality, Pharmacy, or CGMP manufacturing experience preferred.
• Knowledge of USP, FDA, and cGMP regulations preferred.
• Knowledge of how and ability to write, review, and revise SOPs required.
• Ability to read, analyze, and…