What are the responsibilities and job description for the Quality Assurance Supervisor position at Aphena Pharma Solutions-maryland Llc?
Core Quality Functions
- 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
- Assist with the operation of various equipment for Seal Integrity equipment.
- Asist with required in process retain, micro and analytical samples.
- Retrieval of 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 the 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 products, and finished products inspection according to
- Retrieved documents from the EQMS system.
- Written and verbal communication skills are required to communicate issues and procedures among
- 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.
Essential Job Skills
- Knowledge of Current Good Manufacturing Practice (cGMP) Regulations pertaining to medical
- 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 timing manner and complies with cGMP.
- Determine root cause and corrective and preventive action plan for any Investigations, CAPA, and
- Maintain operational efficiency and compliance with all test equipment and processes.
- Provide the necessary QA support needed for the rapid commercialization of new products and
- Perform/assist in any required cGMP validations.
- Ensure the QA Technician are up to date on 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
- Ability to read and understand drawings, templates and other documents. The ability to use the
- Tensile Machine
- Burst Test Machine
- Torque Test Machine
- Seal Integrity Machine
Salary : $70,000 - $75,000