Summary:The Manufacturing Quality Assurance (MQA) Supervisor position directs a team of QA Specialists trained in Manufacturing Quality Assurance. The MQA team is responsible for the quality involvement and oversight of routine operations such as compounding, inspection, labeling and testing activities on site. This team is also responsible for Batch Record review and final product disposition. The MQA Supervisor provides support to the MQA team through scheduling and coordinating MQA activities and driving timely and efficient Batch Record review and product disposition. In this position, the MQA Supervisor also supports the Organization though process-improvement and optimization initiatives as well as drives compliance to the regulations and site procedures.
Essential functions:- Responsible for the MQA program, which includes scheduling and coordinating MQA activities and the assisting with the resolution of any issues that develop
- Responsible for assisting the MQA team in assessing the impact of observations made during MQA oversight
- Ensures MQA support and oversight is provided during Media Fill and Shut-down activities.
- Maintains strong communication network within the MQA team and in all areas of the organization
- Responsible for timely batch release, which includes scheduling and coordinating batch review and release activities and the assisting with the resolution of any issues that develop
- Tracks batch record related corrections and right first-time metrics, reports these metrics to their respective departments, and works with area owners to reduce corrections, improve RFT and ensure an efficient batch release process is maintained
- Performs Quality Assurance final review of validation protocols and reports, quality event investigations, change controls, CAPAs and SOPs
- Proactively looks for opportunities to identify change, increase efficiency, influence decisions, and deliver results while ensuring compliance
- Trains, mentors, and develops direct reports
- Additional responsibilities as assigned
Requirements
Required Qualifications & Experience:- Bachelor's degree in life sciences, engineering, or related discipline.
- 3 years of supervisory experience required
- 5 years working experience in pharmaceutical, medical device or other related industries
Desired Knowledge, Skills, and Abilities:- Proficient in Microsoft Office (Word, Excel, PowerPoint, Outlook)
- Thorough knowledge and understanding of cGMP.
- Experience in pharmaceutical quality unit and aseptic processing preferred.
- Demonstrated skills/abilities in conducting and documenting investigations.
- Is goal and task oriented, has strong sense of urgency.
- Some exposure to regulatory agency inspections (e.g., FDA, notified bodies, etc.).
- Familiarity with regulatory requirements for 503(b) sterile compound outsourcing facilities preferred
- Proven ability to work cross-functionally to achieve business outcomes
