Sr. QA Specialist

Pacira Pharmaceuticals, Inc.•San Diego, CA

8d•$86,000 - $115,000

About The Position

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.

Requirements

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
Strong working knowledge of Quality Systems and applicable US and EU GxP regulations
Ability to analyze data, manage priorities, and support cross-functional quality initiatives
Strong organizational skills with the ability to manage multiple activities concurrently
Effective written and verbal communication skills, with the ability to collaborate across functions
Proficiency in Microsoft Excel, SharePoint, Word, and Adobe Acrobat; experience with MasterControl or similar eQMS platforms preferred

Nice To Haves

Prior experience supporting audits, inspections, complaints, and changing management activities is preferred

Responsibilities

Lead and support nonconformance (NC) identification, investigation, and disposition activities, including Material Review Board (MRB) evaluations, and assessment of product impact.
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.
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.
Support Change Control / Management of Change activities arising from NCs, CAPAs, incoming inspection findings, or validation outcomes, ensuring appropriate evaluation, approval, and closure.
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.
Participate in regulatory agency and third-party inspections by supporting inspection readiness and providing NC, CAPA, MRB, incoming inspection, and validation documentation and responses.
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.
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.
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.
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.
Support cross-functional teams in implementing sustainable corrective actions and verifying their effectiveness.
Perform other duties as assigned by Quality Management.