Quality Assurance Supervisor

Aphena Pharma Solutions•Easton, MD

12d•$70,000 - $75,000•Onsite

About The Position

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 according to document specifications. • 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 documented specifications. • Retrieved 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. Qualifications Essential Job Skills • 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 timing 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 the rapid commercialization of new products and processes. • 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 procedures among multiple departments. • Ability to read and understand drawings, templates and other documents. The ability to use the following equipment is desirable: • Tensile Machine • Burst Test Machine • Torque Test Machine • Seal Integrity Machine

Requirements

Knowledge of Current Good Manufacturing Practice (cGMP) Regulations pertaining to medical devices and pharmaceuticals.
Ability to work with Microsoft Excel, Word, and PowerPoint.
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.

Nice To Haves

The ability to use the following equipment is desirable: • Tensile Machine • Burst Test Machine • Torque Test Machine • Seal Integrity Machine

Responsibilities

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 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 documented specifications.
Retrieved 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.
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 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 the rapid commercialization of new products and processes.
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.
Serve as backup for QA Technician when needed.