Senior Compliance & Quality Auditor

PCI TRGR Penn Pharmaceutical Services Ltd; San Diego (CA); On-site; USD 85,000 - 96,000; Full time

Benefits offered by this job

Health insurance

401(k) plan

Paid time off

Dental and vision coverage

Job summary

PCI Pharma Services in San Diego seeks a Sr. Compliance Associate I to lead customer audits, support internal and vendor audits, and help advance the Quality Management System. The role emphasizes collaboration with SMEs and training team members while maintaining regulatory alignment.

The candidate should have a Life Sciences degree and 6+ years of QA experience in GMP environments, with hands-on QMS software knowledge and strong organizational skills.

Qualifications

• Bachelor's degree in Life Sciences or equivalent required.
• Minimum 6 years of QA experience in a regulated industry.
• GMP manufacturing experience and regulatory knowledge preferred.

Responsibilities

• Leads customer audits, addresses findings with SMEs, tracks program progress.
• Supports vendor management and conducts on-site and paper audits; writes Quality Agreements.
• Executes internal audit program and supports risk management.
• Supports QMS continuous improvement and SOP reviews/approvals.
• Generates quality metrics for management review and trains staff on audits.

Skills

Quality Assurance

Auditing experience

SOP governance

Education

Bachelor's Degree in Life Sciences

Tools

ACE

TrackWise

MasterControl

ETQ

Job description

PCI Pharma Services in San Diego seeks a Sr. Compliance Associate I to lead customer audits, support internal and vendor audits, and help advance the Quality Management System. The role emphasizes collaboration with SMEs and training team members while maintaining regulatory alignment.

The candidate should have a Life Sciences degree and 6+ years of QA experience in GMP environments, with hands-on QMS software knowledge and strong organizational skills.