Supervisor, QA Raw Materials
Job Description
Description
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.
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.
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 for conducting and providing mechanical expertise in the maintenance and repair activities of the manufacturing and facilities equipment and systems in support of scheduled production activities and resolving the day-to-day equipment and facilities related issues. The overarching goal is to ensure that manufacturing systems and support utilities are available as demanded by the manufacturing schedule. This includes maintaining the physical operation of the systems as well as their documented validated state.
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 andaccountability 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.
Supervisory Responsibilities:
This person has direct supervisory responsibilities.
Interaction:
This person interacts with all departments having GMP functions, and works closely with Quality Control, Microbiology, Manufacturing and Supply Operations and on occasion interacts with QP's from different countries to assure regulatory requirements.
Education and Experience:
- Minimum of 5 years of relevant experience required
- 1-2 years of management experience preferred
- Bachelor's degree in a scientific discipline desirable
Qualifications:
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Knowledge, Skills, and Abilities:
- Strong knowledge of cGMPs and their application. Knowledge of both international and US regulatory requirements is preferred.
- Familiarity or prior experience with aseptic processing is preferred
- Proficiency with Microsoft Word and Excel applications required. Proficiency with MasterControl and ESI (ERP) applications preferred.
- Ability to work proactively with managers to solve quality problems
- Ability to manage multiple responsibilities with a high degree of self-motivation
- Excellent written, oral and interpersonal communication skills are required
Physical Demands:
Close vision and the need to focus on computer screen, use of hands, fingers, and wrist to type on keyboard and manipulate mouse. Employee will handle raw materials and finished product, which include cytotoxic, hazardous materials, following appropriate safety measures. Employee may need to transport materials weighing up to 25 kilograms within the facility in the performance of duties. Employee is expected to meet the physical and health requirements for gowning and entry into C/D graded clean rooms.
Work Environment:
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.
The work setting is consistent of a typical pharmaceutical warehouse along with offices and cubicles.
Benefits:
- Medical, Prescription, Dental, Vision Coverage
- Flexible Spending Account & Health Savings Account with Company match
- Employee Assistance Program
- Mental Health Resources
- Disability Coverage
- Life insurance
- Critical Illness and Accident Insurance
- Legal and Identity Theft Protection
- Pet Insurance
- Fertility and Maternity Assistance
- 401(k) with company match
- Flexible Time Off (FTO) and 11 paid holidays
- Paid Parental Leave
The base pay range for this role in California is $80,000 per year to $110,000 per year.
The range is what we reasonably expect to pay for this role. The range considers a wide range of factors that are considered in making compensation decisions, including but not limited to: geographic markets, business or organizational needs, skill sets, experience, training, licensure, and certifications.
EEO Statement: Pacira is proud to be an Equal Opportunity Employer and does not discriminate against applicants because of race, color, religion, sex (including gender identity, sexual orientation, and pregnancy), national origin, age (40 or older), veteran status, disability or genetic information, or any other characteristic protected under applicable federal, state, or local law. At Pacira we are committed to intentionally cultivating a culture of inclusion where all feel welcomed and valued for their background, perspectives, and experiences. We hold one another accountable to promote trust and transparency in support of our communities and collective purpose.
Agency Disclaimer: Pacira Biosciences, Inc. (Hereafter, Pacira) does not accept unsolicited resumes from recruiters or employment agencies in response to the Pacira Careers page or a Pacira social media post. Pacira will not consider or agree to payment of any referral compensation or recruiter fee relating to unsolicited resumes. Pacira explicitly reserves the right to hire said candidate(s) without any financial obligation to the recruiter or agency. Any unsolicited resumes, including those submitted to hiring managers, are deemed to be the property of Pacira.
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