Manufacturing Quality Assurance Supervisor
The Supervisor, Manufacturing Quality is responsible for risk-based decision making to address any issues on the manufacturing floor, materials/components, sampling and inspection. They will serve as the quality management for the operations. This role will provide critical quality expertise to the manufacturing, facilities, engineering, logistics, and work as part of the site quality to management team to oversee investigations and determine CAPA based on thorough root cause analysis. They will be responsible for the key plant metrics for the Quality Management Review meeting (QMR) to ensure a state of control and drive continuous improvement; reporting to Site Head of Quality, all necessary information.
- Work effectively with Operations, Maintenance, Logistics, and Engineering and make time-sensitive, risk-based decisions; escalate issues to quality and operations site heads, as necessary.
- Supervise a team of Manufacturing Quality Associates, across all shifts of operation, who perform real-time on the floor Batch record and logbook review.
- Act as a subject matter expert in the review of SOPs/Documents: documentation, SOPs, instruction sets, specifications, batch record closure, etc. and other quality procedures directly related to operations and other cGMP activities.
- Ensure all non-conformances from specifications and deviations from established procedures are appropriately documented and investigated to determine and root cause, in a timely manner.
- Perform Non-conformance/Deviation/CAPA quality review, approval, and recommend material disposition to Quality Batch Release, author quality owner investigations, and be responsible for ensuring that manufacturing quality related CAPAs are implemented and effective.
- Complete on the unannounced floor quality audits during the manufacturing processes and lead the team/act as Subject Matter Expert during audits of the manufacturing area.
- Independently lead projects to address quality gaps or drive continuous improvement related to Operations or Quality Systems in conjunction with the other quality leaders.
- Participate in the identification of critical systems and parameters, protocol development
- Evaluate, review and approve any protocols that impact the drug product or processes; oversee the qualification and validation activities of facilities, utilities, and equipment
- Ensure that CSPs have verified or validated cleaning procedures are in place
- Review and approve process validation reports that have a direct impact on drug product quality, efficacy, safety, and data integrity.
- Assure that no protocol deviations or errors have occurred or, if errors have occurred, that they have been fully investigated.
- Ensure that all amendments, deviations and conclusions have been documented for closure.
- Develop, implement, and oversee a risk-based quality program for Operations, ensuring routine activities are completed within cGMP compliance and established timelines.
- Act as back-up to Quality Systems Management for the disposition of incoming raw materials.
- Ensure that there is a plan in place to maintain and calibrate manufacturing quality equipment and tools and provide quality oversight for the preventative maintenance of manufacturing equipment and tools.
Experience & Skills Required
- Ability to work across the shift schedule of manufacturing, as required.
- Willing and able to work off shifts (day, night, and/or weekend) as required in the event of training, projects, and other circumstances.
- Strong leader with an expert level understanding of GMP requirements, acute attention to detail, and ability to assess risk to product quality and compliance.
- Provide guidance, coaching, and training Operations, Maintenance, Logistics, and Engineering to drive continuous improvement and achieve company goals.
- Excellent oral and written communication skills with strong technical writing experience required.