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Quality Assurance Floor Support Supervisor
2 months ago
We are seeking a highly skilled Quality Assurance Floor Support Lead to join our team at BioSpace, Inc. in Concord, North Carolina. As a key member of our Quality Assurance department, you will be responsible for providing leadership to a team of QA Specialists, ensuring adherence to safety rules, and maintaining a safe work environment.
Key Responsibilities- Lead and mentor a team of 6-10 Quality Specialists supporting parenteral operations, ensuring they have the necessary training and resources to perform their duties effectively.
- Ensure adherence to good documentation practices and compliance with applicable procedures for both Operations and Support personnel.
- Monitor GMP programs and quality systems in preparation, formulation, filling, and visual inspection areas to identify areas for improvement.
- Assess, create, and triage deviations/observations that occur within the parenteral areas, and develop corrective actions to prevent recurrence.
- Review and approve GMP documentation, including maintenance action plans, return to service, and release of equipment, product, and area holds.
- Provide QA systems support to reconcile issues in multiple systems, including SAP, PMX, TrackWise, SmartLab, GMARS, and other systems as required.
- Participate in self-led inspections and provide support during internal/external regulatory inspections.
- Communicate with Associate Director and Quality Representatives on quality and operational issues.
- High School Diploma or equivalent.
- 5 years of experience in a quality leader role supporting parenteral manufacturing operations.
- Bachelor's degree in a science, engineering, computer, or pharmaceutical-related field of study.
- Demonstrated strong oral and written communication and interpersonal skills.
- Demonstrated decision-making and problem-solving skills.
- Demonstrated knowledge and understanding of manufacturing processes and Quality Systems.
- Proficiency with inventory management systems and deviations systems.
We offer a competitive salary and benefits package, as well as opportunities for professional growth and development. If you are a motivated and detail-oriented individual with a passion for quality assurance, we encourage you to apply for this exciting opportunity.
