Quality Compliance Auditor

Technical Operations San Diego, CA


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. Our in-depth knowledge of non-opioid pain management, coupled with our passion for advancing patient care, drives our commitment to providing solutions that address unmet medical needs and improve clinical results.

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.

The purpose of this position is to conduct and manage Quality Assurance External and Internal GMP Audits and to assure compliance with the GXP Audit Program.  The audits will be primarily focused on current Good Manufacturing Practices (GMP) but may include conformance to ISO standards where implemented.  The position will also be responsible for managing Quality Agreements and the Supplier/Vendor Qualification Program.

Responsibilities:

  • Maintain GXP audit program for external supplier audits.
  • Perform GXP external audits per Pacira’s annual Master Audit Schedule.
  • Prepare GXP external audit reports with details on audit scope and observations of non-compliance.
  • Assist with regulatory inspections and partner audits.
  • Conduct annual Mock Recall for commercial products.
  • Create and author Standard Operating Procedures (SOPs) as needed to support GXP external audits.
  • Recommend corrective and preventive actions as need to support compliance within the department.
  • Manage and maintain the Quality Agreements.
  • Manage and maintain the Supplier/Vendor Qualification Program
  • Other duties as assigned.

Qualifications:

  • 1-3 years of relevant GMP Quality audit experience.
  • BS/BA degree in scientific discipline from an accredited college or university or equivalent experience preferred.
  • Strong knowledge of US and EU GMPs and their application.
  • Working knowledge of GCP and GLP regulations and requirements.
  • Ability to use Microsoft Word and Excel applications.
  • Ability to work proactively and cooperatively with managers and operational staff to solve quality problems.
  • Ability to manage multiple responsibilities with a high degree of self motivation.
  • Good written, oral and interpersonal English communication skills.
  • Understanding of Quality Agreements.
  • Knowledge of Supplier/Vendor compliance

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.