Life 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 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.
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.
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Join 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.
Skills Required
- Bachelor's degree in a Life Sciences discipline or equivalent experience
- Minimum of 6 years relevant QA experience in a regulated industry
- At least 2 years manufacturing experience in a GMP environment or Drug Product Manufacturing
- Advanced-level understanding of regulatory requirements related to aseptic drug product manufacturing and testing
- Knowledge and hands-on experience with QMS data management software (ACE, TrackWise, MasterControl, ETQ, etc.)
- Experience leading customer and regulatory audits and executing internal audit programs
- Experience supporting vendor management, performing on-site and paper audits, and establishing Quality Agreements
- Experience reviewing and approving SOPs, deviation reports, and CAPAs
- Strong collaboration, training, organizational and attention-to-detail skills
PCI Pharma Services Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about PCI Pharma Services and has not been reviewed or approved by PCI Pharma Services.
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Retirement Support — Feedback suggests the company provides a 401(k) with an employer match in the mid‑single‑digit range, with immediate vesting noted in certain cases. This is viewed as a solid component of the overall package.
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Leave & Time Off Breadth — PTO and paid holidays are commonly available, and some roles indicate vacation is accessible from early tenure. Availability of time off is frequently described as a positive element of the package.
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Affordable Benefits — Health insurance is sometimes described as reasonably priced depending on plan tier. Feedback suggests core medical, dental, and vision coverage is part of a standard offering.
PCI Pharma Services Insights
What We Do
PCI is a leading provider of integrated pharmaceutical development services to the global healthcare market. With facilities in North America and Europe, PCI supports pharmaceutical and biotech companies with products destined for more than 100 countries around the world. PCI provides services for each stage of the product lifecycle – from early Phase I through commercial launch and long-term supply – and partners with customers to provide key insight and expertise in enabling successful commercialization and bringing lifesaving medications to patients. For more information, go to www.pci.com.
