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Supervisor, Quality Control
Avid BioservicesUnited Statesfull_timeVerifiedPosted 21 Apr 2025
💰 $90,300/yr($67,700/yr – $90,300/yr)
About the role
Looking to join a passionate team dedicated to developing and manufacturing life-saving biopharmaceuticals? Avid Bioservices is a leading clinical and commercial biologics CDMO focused on creating innovative solutions to meet the needs of our clients and improve patient outcomes. Your Role: The Supervisor, Quality Control provides leadership and oversees the day-to-day operations of the Quality Control Raw Materials group. The position will supervise the performance and development of direct reports to ensure organization and department goals are met. The Supervisor, Quality Control must have strong technical skills and GMP experience and extensive knowledge of raw material compendia. They will lead and support continuous improvement initiatives, perform basic compendial test methods without supervision and with strict adherence to written protocols, analyze data and report results.
- Review analytical data for the sampling, testing and release of raw materials.
- Assess/review raw material classifications and testing requirements.
- Write/revise raw material specifications.
- Monitor progress of individuals and teams of QC analysts toward departmental goals.
- Plan and create QC schedules to accommodate manufacturing support and client support.
- Ensure that all instruments are calibrated and that performance verifications and routine maintenance are performed on a routine basis as stipulated in the respective SOPs.
- Supervise analysts in their work assignments and identify needs for further training.
- Ensure adherence to regulatory compliance and cGMPs.
- Provide reviews and feedback including evaluations and ensure correct billing of time and materials to clients.
- Approve the timesheets of all reports.
- Facilitate or coordinate training for QC personnel in the areas of regulations and compliance.
- Ensure thorough and proper documentation of activities in respective logbooks and complete reviews.
- Perform instrument troubleshooting and train QC personnel in existing methods and instruments.
- Lead or designate a lead for laboratory assessment and investigations related to out of specifications and out of tolerance results.
- Interact with internal customers from cross-functional groups such as product development, manufacturing, quality assurance and research and development to ensure adequate QC support for those groups.
- Be responsible for thorough knowledge of cGMP and regulatory requirements and ensure compliance.
- Assess vendor change notifications (VCN).
- Assess compendial changes.
- Interface with contract testing labs.
- Interface with the client to discuss raw material specifications/qualifications.
- Perform other duties as assigned.
- B.S. degree in Chemistry or Biology.
- Minimum of 5 years of life science industry experience in a QC or analytical lab
- Experience with the following is essential: raw material testing and release, analytical testing and equipment, writing reports/procedures/specifications, GMPs and regulatory audits.
- 1-2 years of supervisory experience.
- You have a "bring it on!" team player approach and an unshakable positive attitude, always ready to tackle anything that comes your way.
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