Sr. Compliance Associate I

PCI TRGR Penn Pharmaceutical Services Ltd; San Diego (CA); On-site; USD 41,000 - 46,000; Full time

Job summary

PCI Pharma Services in San Diego seeks a Sr. Compliance Associate I to lead customer audits, support internal audits, and help manage the vendor program within a robust Quality Management System. The role suits a person with extensive QA experience and strong collaboration skills.

The ideal candidate will review SOPs, deviation reports, and CAPAs, train teammates on auditing processes, and contribute to continuous quality improvements in a GMP environment.

Qualifications

• Bachelor's degree in Life Sciences or equivalent.
• Minimum 6 years of QA experience in a regulated industry.
• Advanced understanding of regulatory requirements for aseptic drug product manufacturing and testing.
• Hands-on experience with QMS data management software (ACE, TrackWise, MasterControl, ETQ).
• Strong collaboration, auditing, and training skills.

Responsibilities

• Lead customer audits and coordinate with SMEs to address findings.
• Support vendor management program and conduct on-site/paper audits; establish Quality Agreements.
• Support internal audit program and risk management activities.
• Contribute to continuous improvement of the Quality Management System.
• Review and approve SOPs, deviation reports, and CAPAs.
• Generate quality metrics for management reviews and train staff on audits.

Skills

Audit leadership

Audit coordination

Quality Management System

Regulatory compliance

Cross-functional collaboration

Training team members

Education

Bachelor's Degree in Life Sciences

Tools

ACE

TrackWise

MasterControl

ETQ

Job description

## Sr. Compliance Associate IApplylocations: San Diego, CA, USAtime type: Full timeposted on: Posted Todayjob requisition id: JR119189Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.**We are PCI.**Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.**SUMMARY:**The Sr. Compliance Associate I will utilize their skills to hosts customer and regulatory audits, assist in the execution of internalaudits, and provide support to the vendor management program. This role is a great fit for a candidate who is both personable andhighly knowledgeable of the Quality Management System.**Shift:1st****ESSENTIAL JOB FUNCTIONS-OTHER DUTIES MAY BE ASSIGNED:*** 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 [or in accordance with posted schedule].* 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 Serivices cultural values and aligns daily actions with department goals and company culture.**EDUCATION AND EXPERIENCE:*** 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.The hiring rate for this position is $29.65 - $33.36 plus eligibility for an annual performance bonus. Final offer amounts are determined by multiple factors, including but not limited to specific and relevant experience, education, credentials, geography, and subject matter expertise. PCI offers full-time employees a competitive benefits package that includes paid time off, health insurance coverage (including dental and vision), a flexible spending account, and a 401(k) plan.#LI-AC1Join us and be part of building the bridge between life changing therapies and patients. Let’s talk future**Equal Employment Opportunity (EEO) Statement:** *PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.**At PCI, Equity and Inclusion are at the core of our company’s purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity – at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.*