Senior Compliance Associate I - QA & Regulatory Audits

PCI Pharma Services; San Diego (CA); On-site; USD 41,000 - 47,000; Full time

Benefits offered by this job

Paid time off

Health insurance coverage

401(k) plan

Flexible spending account

Job summary

PCI Pharma Services in San Diego is seeking a Sr. Compliance Associate I to lead customer audits and support the internal audit program within a GMP environment. You will collaborate with SMEs to address findings, help establish Quality Agreements, and support the vendor management program.

The role requires a Life Sciences degree and a minimum of 6 years in QA, with strong regulatory knowledge and experience in GMP drug product manufacturing. A comprehensive benefits package is provided.

Qualifications

• Bachelor's degree in Life Sciences or equivalent experience.
• Minimum 6 years of QA experience in a regulated industry.
• 2+ years of GMP manufacturing experience preferred.
• Strong regulatory knowledge for aseptic drug product manufacturing.
• Hands-on experience with QMS data management software.

Responsibilities

• Lead customer audits and coordinate with SMEs to address findings.
• Support vendor management, on-site or paper audits, and QA agreements.
• Support internal audit program and risk management activities.
• Contribute to continuous improvement of the QMS and SOPs.
• Generate quality system metrics for management reviews.
• Train team members on internal and external audits.
• Maintain consistent attendance and professional conduct.

Skills

Audit leadership

Regulatory knowledge

Communication skills

Training teammates

Education

Bachelor's Degree in Life Sciences

Tools

ACE

TrackWise

MasterControl

ETQ

Job description

PCI Pharma Services in San Diego is seeking a Sr. Compliance Associate I to lead customer audits and support the internal audit program within a GMP environment. You will collaborate with SMEs to address findings, help establish Quality Agreements, and support the vendor management program.

The role requires a Life Sciences degree and a minimum of 6 years in QA, with strong regulatory knowledge and experience in GMP drug product manufacturing. A comprehensive benefits package is provided.