Manager Quality Assurance

The Quality Assurance Manager reports to the Director of Quality, Global Inhalation and is responsible for directly overseeing the Quality Assurance activities in the manufacturing and packaging areas. This Manager will be responsible for monitoring the activities of the shift Quality Assurance Technicians including in-process sampling of multiple finished dosage forms, incoming raw materials and component sampling, and proper documentation of all Quality Assurance functions.

Essential Duties and Responsibilities

• Conduct Manufacturing and Packaging deviation investigations when a deviation occurs, including writing the investigation reports. Appropriately route written investigations through QA management channels in a timely manner.
• Conduct ongoing performance reviews and evaluations for shift Quality Assurance Technicians including coaching and mentoring to further develop skills and knowledge
• Manage the scheduling of the shift Quality Assurance Technicians, properly manage requests and receive management approval for overtime when needed.
• Proactively make recommendations for SOP updates, as well as seek opportunities to identify efficiencies in the daily Quality functions
• Ensure proper GMP compliance and SOP procedures are followed at all times, as well as follow all safety and environmental guidelines
• Oversee, and at times perform hands-on sampling, inspecting of incoming raw materials, in-process intermediates and purchased finished products and submitting samples to the QC laboratory for analysis
• Manage the material status from Quarantine to Release/Reject and vice versa
• Monitor the manufacturing equipment/rooms and packaging lines/ equipment for cleanliness and approve them prior to the start of the operation
• Supervise and at times perform QA in-process checks (Beginning, Middle and End) for manufacturing/packaging operations and determine the results meets against pre-determined standards and batch record requirements
• Appropriately guide the QA Technician team to perform AQL inspections on finished dosage forms against pre-determined Quality Attributes.
• Manage the collection and maintenance of samples from all products manufactured. Assure that all retains are stored in an appropriate manner for accountability, annual inspection and retrieval.
• Oversee the sampling and proofreading of all pharmaceutical labeling for conformance to the standard. Issues approved labels to the packaging lines for use.
• Utilize software programs such as QAMS, SABA (LMS), and SAP for various tracking of daily work activities as well as training
• Immediately address any Quality issues brought forward by the Quality Assurance Technicians
• Perform other QA duties as assigned

• 5+ years’ prior experience in a Quality Assurance role, preferably with experience managing others
• Bachelor’s Degree in a scientific or related field
• Excellent communication skills
• Attention to detail is paramount
• Desire to achieve high quality of work and diligent about following Standard Operating Procedures
• Able to effectively manage and mentor a team and adapt to changes in work duties
• Detail-oriented, thorough and methodical, and able to follow timeline
Physical Requirements
The physical requirements of the position generally include: standing, walking, sitting, using hands and fingers, reaching with hands and arms, talking and hearing. In some circumstances, bending, kneeling, crouching, stooping, and crawling may apply. This position may require lifting up to 15 pounds occasionally. Generally work is performed in a warehouse or manufacturing environment.