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Senior Compliance Associate I

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PCI Pharma Services

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Location:
United States , San Diego

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Category:
Quality Control

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Contract Type:
Not provided

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Salary:

40.92 - 46.04 USD / Hour
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Job Description:

The Sr. Compliance Associate I will utilize their skills to hosts customer and regulatory audits, assist in the execution of internal audits, and provide support to the vendor management program. This role is a great fit for a candidate who is both personable and highly knowledgeable of the Quality Management System.

Job Responsibility:

  • Leads customer audits, collaborates with Subject Matter Experts to address audit findings, and tracks the customer audit program for continuous improvement
  • Supports vendor management program, occasionally conducts on-site and paper audits, and establishes Quality Agreements
  • Supports the execution of internal audit program
  • Supports risk management program
  • Supports the continuous improvement of the Quality Management System
  • Reviews and approves quality management system standard operating procedures (SOPs)
  • Reviews and approves deviation reports and CAPAs related to quality systems
  • Generates quality system metrics for management review meetings
  • Trains team members on conducting internal and external audits
  • Regular and reliable attendance on a full time basis
  • Responsible for exhibiting professional behavior with both internal and external business associates that reflects positively on the company and is consistent with the company’s policies and practices
  • Embodies PCI Pharma Services cultural values and aligns daily actions with department goals and company culture

Requirements:

  • Bachelor's Degree in a Life Sciences discipline or equivalent relevant experience required
  • Minimum of 6 years of relevant QA experience in a regulated industry
  • At least two (2) years relevant experience of manufacturing in a GMP environment or Drug Product Manufacturing Preferred
  • Advanced-level understanding of regulatory requirements related to aseptic drug product manufacturing and testing
  • Knowledge and hands on experience with QMS data management software such as ACE, Track Wise, Master Control, ETQ, etc.
  • Highly effective in collaborating with internal and external customers, leading improvement projects, and training team members on internal and external auditing
  • Detail-oriented with strong organizational skills
What we offer:
  • Paid time off
  • Health insurance coverage (including dental and vision)
  • Flexible spending account
  • 401(k) plan
  • Eligibility for an annual performance bonus

Additional Information:

Job Posted:
February 20, 2026

Employment Type:
Fulltime
Work Type:
On-site work
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