Compliance Associate II

PCI Pharma Services 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. Perform moderately complex activities pertaining to assuring compliance with applicable regulatory requirements. Conduct internal audits; assist with customer audits, and track audit corrective actions. Essential duties and responsibilities include: Assists with internal audit program by conducting audits, writing audit reports, evaluating responses to audit observations, and verifying closure of corrective actions. Assists with vendor quality program by conducting paper audits and tracking vendor quality issues and changes. Assists with customer audit program by retrieving and preparing documentation, communicating and coordinating with internal SMEs, and tracking completion of corrective actions. Assists with regulatory inspection process by retrieving requested documentation and communicating with SMEs. 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's cultural values and aligns daily actions with department goals and company culture. Qualifications include: Bachelor's degree in Life Sciences discipline or equivalent preferred. Minimum of two to four (2-4) years of experience in a GMP environment. Basic understanding of regulatory requirements related to aseptic drug product manufacturing and testing; Good understanding of internal requirements related to quality management systems, risk management, and supplier qualification; Developing communication and team collaboration skills Detail-oriented with strong organizational skills; Proficient with Microsoft Office applications Physical demands include: Constantly required to sit, and to reach to use computers and other office equipment Constantly stand for extended periods of time, up to four (4) hours/time. Frequently required to lift up to 40 pounds Constantly required to view objects at close and distant ranges with hand and eye coordination Frequently required to communicate with others Work environment is fast-paced and demanding. Employee may occasionally be exposed to fumes, airborne particles, toxic chemicals, vibration, and bio-hazardous materials. The hiring rate for this position is $32.92 - $37.04 per hour plus eligibility for an annual performance bonus. 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.

Created: 2026-03-10