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Supervisor, QA Raw Materials
Pacira BioSciences, Inc.San Diego, United Statesfull_timeVerifiedPosted 11 Jun 2024
💰 $110,000/yr($80,000/yr – $110,000/yr)
About the role
About Pacira
Pacira BioSciences, Inc. is a leading provider of non-opioid pain management and regenerative health solutions dedicated to improving outcomes for health care practitioners and their patients. Each of our 3 marketed products, both in pharmaceutical and medical device, represent cutting edge technologies for pain management. We have 700+ employees and have averaged double digit growth year over year for the past 5 years, with $500M in revenue. We are small enough for you to make your mark, and big enough for you to learn and grow! We have facilities in New Jersey, California and Florida. Our San Diego, CA campus is a world class manufacturing and R&D facility. We are rapidly growing and have opportunities across all of our sites and functional areas.
Why work with us?
Rarely do you have an opportunity to do work that really matters. What drives us is our mission. What makes us successful are our people. At Pacira, you are part of an inclusive culture that fosters collaboration, growth, and innovative thinking – a place where you can make an impact and help change the standard of care in non-opioid pain management. Be part of our movement, let’s pursue excellence together. Summary: The purpose of this position is to provide organizational management and leadership to the Quality Assurance-Raw Material department and ensure cGMP compliance of all operational areas. Essential Duties & Responsibilities:
Pacira BioSciences, Inc. is a leading provider of non-opioid pain management and regenerative health solutions dedicated to improving outcomes for health care practitioners and their patients. Each of our 3 marketed products, both in pharmaceutical and medical device, represent cutting edge technologies for pain management. We have 700+ employees and have averaged double digit growth year over year for the past 5 years, with $500M in revenue. We are small enough for you to make your mark, and big enough for you to learn and grow! We have facilities in New Jersey, California and Florida. Our San Diego, CA campus is a world class manufacturing and R&D facility. We are rapidly growing and have opportunities across all of our sites and functional areas.
Why work with us?
Rarely do you have an opportunity to do work that really matters. What drives us is our mission. What makes us successful are our people. At Pacira, you are part of an inclusive culture that fosters collaboration, growth, and innovative thinking – a place where you can make an impact and help change the standard of care in non-opioid pain management. Be part of our movement, let’s pursue excellence together. Summary: The purpose of this position is to provide organizational management and leadership to the Quality Assurance-Raw Material department and ensure cGMP compliance of all operational areas. Essential Duties & Responsibilities:
- Review raw material data records to support the release of raw material lots. This includes Quality Control (QC) and Microbiology test data and raw material quality certificates.
- Perform quarantine, sampling and release functions for raw materials including labeling of materials and assignment of expiration/retest dates.
- Review and release incoming raw materials at the main campus.
- Oversee the maintenance and compliance of quarantine areas, grade C/D raw material sampling cleanrooms and calibration of applicable instrumentation.
- Oversee ESI inventory software transactions and accountability of quarantine inventory through weekly cycle counts and annual audits. This will also include maintaining lot history/disposition databases, cycle time metrics for quarantined, released lots of raw materials and monthly inventory cycle counts for quarantined raw-materials and components. Evaluate variance reports, investigates discrepancies, and recommends corrective actions.
- Provide information for Annual Product Reviews and regulatory filings.
- Lead, facilitate or support investigations for quality events to include non-conformance material Reports (NCMRs).
- Support/participate in activities for the qualification of new raw materials and components, which include Supplier Qualification, Specification Committee and CMC.
- Support Supplier Change Notifications by tracking progress and follow-up on actions to ensure closure.
- Write, revise and review policies, procedures and protocols associated with raw material job functions.
- Act as the primary point of contact to Procurement and Supply Operations regarding raw material suppliers on technical and quality issues.
- Assist with regulatory inspections and partner audits.
- Provide floor support and supervision during activities on an as-needed basis.
- Evaluate variance reports, investigate discrepancies and recommend corrective actions.
- Perform additional responsibilities as assigned by QA Management.
- Minimum of 5 years of relevant experience required
- 1-2 years of management experience preferred
- Bachelor’s degree in a scientific discipline desirable
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