Quality Assurance Supervisor

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orsunuzto apply for the Quality Assurance Supervisor Aphena Pharma Solutions, Inc.

• Record data and maintain accurate records per Current Good Documentation Practices (cGMP).
• Assist with generating and approving controlled labels using programs provided.
• Approve lot information during generation of a work order.
• Assist with First Piece Approval (FPA) and in‑process hourly inspection of finished good product according to document specifications.
• Assist with the operation of various equipment for Seal Integrity.
• Assist with required in‑process retention, micro and analytical samples.
• Retrieve documents using the EQMS computer system.
• Review all paperwork daily for accuracy and completeness.
• Assist in maintaining the quality management system compliance with regulations.
• Ensure that equipment is maintained and records kept.
• Assist and ensure nonconformances are initiated and reported promptly.
• Assist in the generation and resolution of corrective and preventive action plans.
• Ensure equipment is calibrated before use.
• Assist in maintaining the quality system.
• Troubleshoot quality concerns that may arise and report to QA Manager.
• Assist in incoming component, in‑process product, and finished product inspection according to documented specifications.
• Retrieve documents from the EQMS system.
• Written and verbal communication skills are required to communicate issues and procedures among multiple departments.
• Read drawings, templates and other documents.
• Manage multiple product lines in a time‑sensitive environment.
• As needed, work overtime, weekends, or alternate shifts.
• Assist in the development and writing of SOPs, Work Instructions, and Forms, as required.

• Knowledge of Current Good Manufacturing Practice (cGMP) regulations pertaining to medical devices and pharmaceuticals.
• Manage daily activities of QA Technician group to ensure support for business operations.
• Train QA Technician personnel in all aspects of the quality duties to ensure compliance.
• Complete performance review and performance documentation for QA Technicians.
• Ensure paperwork is completed within a timely manner and complies with cGMP.
• Determine root cause and corrective and preventive action plan for any investigations, CAPA, and OOS issues related to the area of responsibility and complete related documentation.
• Maintain operational efficiency and compliance with all test equipment and processes.
• Provide the necessary QA support needed for rapid commercialization of new products and processes.
• Perform/assist in any required cGMP validations.
• Ensure QA Technicians are up to date on splashgino training to comply with the cGMP.
• Review in‑process batch records and equipment notebooks daily.
• Ability to work with Microsoft Excel, Word, and PowerPoint.
• Serve as backup for QA Technician when needed.
• Superior written and verbal communication skills are required to communicate issues and procedures among multiple departments.
• Ability to read and understand drawings, templates and other documents.

• Tensile Machine
• Burst Test Machine
• Torque Test Machine
• Seal Integrity Machine

Mid‑Senior level

Full‑time

Quality Assurance

Pharmaceutical Manufacturing