Sr. QA Specialist

At Pacira, innovation meets purpose.

Pacira BioSciences, Inc. is a pioneer in non-opioid pain management and regenerative health solutions. Today, we're building on that legacy with next-generation innovations for chronic, postsurgical, and musculoskeletal pain. Our culture is built on collaboration, innovation, and a shared commitment to helping patients recover faster. We are redefining what's possible in pain management-and we can't do it without talented people like you.

Why Join Us?

At Pacira, every career is more than a job. Our mission drives us, and every day, we challenge ourselves to achieve the extraordinary. Integrity is at the core of who we are. We value diverse perspectives and the collective strength of a unified team. Join the team in making better possible for patients everywhere.

Summary:

This role is responsible for supporting and executing Quality Assurance and Quality Compliance activities to ensure cGxP compliance across the organization. This role serves as a key contributor to compliance initiatives, quality system maintenance, and inspection readiness while partnering closely with cross-functional teams.

Essential Duties & Responsibilities:

1. Lead and support nonconformance (NC) identification, investigation, and disposition activities, including Material Review Board (MRB) evaluations, and assessment of product impact.
2. Review and approve incoming inspection results and perform final batch record review and disposition to ensure compliance with approved specifications, quality requirements, and release criteria.
3. Exercises independent judgement to perform root cause analysis and support the development, implementation, and effectiveness verification of corrective and preventive actions (CAPAs), ensuring timely documentation, tracking, and closure in accordance with Pacira quality system requirements.
4. Support Change Control / Management of Change activities arising from NCs, CAPAs, incoming inspection findings, or validation outcomes, ensuring appropriate evaluation, approval, and closure.
5. Review, approve, and support validation and qualification activities (e.g., IQ/OQ/PQ, process and equipment validations) associated with investigations, supplier issues, or continuous improvement initiatives.
6. Participate in regulatory agency and third-party inspections by supporting inspection readiness and providing NC, CAPA, MRB, incoming inspection, and validation documentation and responses.
7. Coordinate the Calibration and Preventive Maintenance (PM) Program, ensuring compliance with internal procedures, accurate tracking of calibration and PM status and records, timely execution of activities, and assessment of product impact for missed, overdue, or failed calibrations or PMs, including initiation of NCs or CAPAs as required.
8. Review and approve SOPs, POLs, work instructions, and validation protocols/reports impacted by investigation, CAPA, incoming inspection, or validation activities to ensure compliance with internal and regulatory requirements.
9. Trend and analyze NC, CAPA, MRB, and incoming inspection data to identify recurring issues, systemic gaps, and opportunities for continuous improvement, while promoting a strong quality culture.
10. Support internal audit activities, including audit preparation, execution support, documentation review, and timely follow-up and closure of audit observations, ensuring compliance with internal procedures and regulatory requirements.
11. Support cross-functional teams in implementing sustainable corrective actions and verifying their effectiveness.
12. Perform other duties as assigned by Quality Management.

Responsibilities:

This position does not have supervisory responsibilities.

Education and Experience:

• Five (5) years of relevant Medical Device or similar industry experience required
• BS degree in Chemistry/Biology Engineering highly desirable
• Experience in a manufacturing environment required

Qualifications:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The qualifications listed below represent the knowledge, skills, and abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.

Knowledge, Skills, and Abilities:

1. Strong working knowledge of Quality Systems and applicable US and EU GxP regulations
2. Ability to analyze data, manage priorities, and support cross-functional quality initiatives
3. Strong organizational skills with the ability to manage multiple activities concurrently
4. Effective written and verbal communication skills, with the ability to collaborate across functions
5. Prior experience supporting audits, inspections, complaints, and changing management activities is preferred
6. Proficiency in Microsoft Excel, SharePoint, Word, and Adobe Acrobat; experience with MasterControl or similar eQMS platforms preferred

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.

Typical office setting, cubicles, noise level is moderate with consistent printer, telephone ringing and conversation. The work environment also includes warehouse and manufacturing areas.

Physical Demands:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

May regularly sit, talk, move between spaces, reach with hands and arms and stoop. Regularly focus on a computer screen and use hands, fingers and wrists to type on keyboard and manipulate mouse.

• 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

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.