Pacira BioSciences, Inc. · 12 hours ago
Sr. QA Specialist
San Diego, CA
Full-time
Onsite
Senior Level
$86K/yr - $115K/yr
5+ years expPacira BioSciences, Inc. is a pioneer in non-opioid pain management and regenerative health solutions. This role is responsible for supporting and executing Quality Assurance and Quality Compliance activities to ensure cGxP compliance across the organization, serving as a key contributor to compliance initiatives and quality system maintenance.
Pharmaceuticals
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
Qualification
Required
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
Preferred
Prior experience supporting audits, inspections, complaints, and changing management activities is preferred
Proficiency in Microsoft Excel, SharePoint, Word, and Adobe Acrobat; experience with MasterControl or similar eQMS platforms preferred
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
Company
Pacira BioSciences, Inc.
Guided by our belief that better is possible, we innovate and deliver therapies that reimagine life beyond pain, empowering patients and clinicians with advanced options that challenge the status quo of care.
501-1000 employees
Funding
Current Stage
Late StageLeadership Team
Frank Lee
Chief Executive Officer
Charles A Reinhart, III
Chief Financial Officer
Company data provided by crunchbase