About the JobThe Quality Assurance Supervisor is a leadership level position that has direct reports and is responsible for quality assurance activities associated with cGMP manufacturing, documentation, and product disposition or compliance and quality systems. Ensures that proper controls are followed and maintained during the manufacturing, processing, packaging, and warehousing of compounded products. Or, ensures that site quality systems are operating as intended meeting compliance requirements.
Key Responsibilities- Coach and facilitate direct reports' proficiency in all Level 1, Level 2, and Level 3 Quality Assurance tasks:
- Level 1:
- Manufacturing / Packaging Line Clearances
- Product Label Review and Approval
- Product Label Reconciliation
- EMS Data Review
- Logbook Review and reconciliation
- Level 2:
- Batch Record Issuance
- Batch Record Review and Approval
- Incoming Material Review and Approval
- Form and Logbook Issuance
- Review and Approval of Testing Data
- Review and Approval of Event Reports and Associated Corrective Actions
- Level 3:
- Disposition and Release of Incoming Materials
- Disposition and Release of Finished Product
- Document Control Activities
- Review and Approval of Change Controls and controlled document changes
- Review and Approval of Moderate Risk Deviations
- Will have a min of three and a max of seven direct reports at the QA Generalist, Specialist, or Officer levels.
- Completes administrative leadership tasks including, but not limited to task scheduling, KPI tracking, and individual performance monitoring.
- Demonstrated Subject Matter Expertise or ability to develop expertise in QA responsibilities relevant to assigned QA group (e.g. MQA, QS and Compliance, or other.)
- Takes on QA projects of low to high complexity as assigned.
- Support execution of product Batch Records and associated manufacturing and Quality related systems for the compounding processes.
- Provide QA and compliance guidance and decision making for all manufacturing functions.
- Ensure day-to-day compliance to all requirements established for compounded product and the systems supporting compounding.
- Lead or assist with problem identification and resolution efforts for quality related issues associated with compounding operations.
- Lead or assist with internal, corporate, 3rd party and federal/state inspections and audits.
- Lead compilation and analysis of information on measures of local quality system effectiveness such as right the first time, documentation errors and others as assigned.
- Ensure cGMP documentation associated with work activities meets ALCOA standards.
- Maintain assigned training standard operating procedures. Monitor training requirements of direct reports.
- Perform other related duties as assigned.
Basic Qualifications- College Degree and greater than ten years cGMP experience in a pharmaceutical manufacturing company or equivalent combination of education and cGMP experience is required.
- Experience with quality systems, aseptic technique, cGMP document review, quality investigations, CAPA, Change Control and MasterControl preferred.
- Proficient in MS Office programs, including Word and Excel.
- Ability to process information rapidly from multiple sources and communication channels.
- Ability to handle a high volume of work and rapidly adapt to changing environment.
- Ability to make quality and compliance decisions for the site and/or to escalate any questions.
What's on Offer?Fagron offers its associates competitive salaries and a wide range of benefits including a 401(k) plan with a company matching contribution; medical, vision and dental; health savings account (HSA); holiday/paid time off.
At Fagron, you'll find plenty of chances to grow - both personally and professionally. We work in an open, dynamic environment where your ideas and talents can shine.
