Quality Control Supervisor

Job Description: Quality Control Supervisor is responsible for working closely with the Quality Assurance Director to assist in the development and maintenance of Quality Management Systems at VetStem. These systems will ensure the safety, efficacy, and purity of the products manufactured by VetStem. The VetStem manufacturing facility is a state-of-the-art, GMP and GTP compliant controlled clean room facility designed to enable production of regenerative medicine products.

Primary Responsibilities:

Develop and maintain the following systems:

• Environmental Monitoring Program management, including monitoring, trending, reporting, and coordination of EM validations.
• QC assay Validations/Suitability testing (Management, Protocols and Reporting)
• Management of Equipment Calibrations and OOT Response
• Management of Raw Material Program (Specification development, inspection, testing and release)
• QC testing (intermediate and final product release)
• Maintain the stability program

Management of the Stability program

• Deviation Management including OOS, OOT, and associated investigations, CAPAs.
• Sample management and tracking program
• Management of QC Record keeping and archiving

Support QA with the day-to-day management of the following

• Reporting and organization of Quality Control test results
• Issue batch records and labels
• Assist in review of completed records prior to filing in Records Management
• Maintain technical report and change control files
• Assist in deviation investigations and coordination of corrective and preventive actions (CAPA)
• Write and review Standard Operating Procedures
• GMP QC compliance in the manufacture of products

Secondary Responsibilities:

• Support FDA inspections, internal audits from 3rd parties, and external audits, including completion of customer supplier evaluations and review of supplier agreements
• Support production and manufacturing activities as needed
• Assist in training staff on regulatory requirements and internal procedures as applicable
• Perform additional job-related duties as required

Minimum Requirements:

• 2 years of experience in a Quality Control/Quality Assurance role; prior experience within a cGTP/cGMP regulated biotech, cell processing, tissue bank or pharmaceutical company preferred
• Demonstrated ability to manage and prioritize multiple projects and meet deadlines
• Excellent time management and organizational skills
• Strong written and verbal communication skills
• Understanding of the fields of aseptic processing, cell therapy and cryopreservation preferred
• Exceptional analytical skills and solutions-oriented approach to problem-solving
• Ability to work effectively in a fast-paced, rapidly changing environment
• Demonstrated ability to work independently as well as part of an integrated team
• Flexibility and dedication: Position may require some “off-standard hours”

Direct Report: Quality Assurance Director

Minimum Years Experience: 2-5

Travel: local, within commuting distance of Poway, CA 92064

Minimum Degree: BS in related field or equivalent experience.

FSLA: Full-Time Exempt

Schedule: M-F may require some “off-standard hours”

Pay: $74,700.00 - $89,900.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Flexible spending account
• Health insurance
• Health savings account
• Life insurance
• Vision insurance

Work Location: In person

Salary : $74,700 - $89,900