Compliance Specialist
Hybrid · Summit, New Jersey, United States
Job Summary
Compliance Specialist, Equipment Commissioning & Qualification supports facility, laboratory, and business operations by ensuring the ECQ group remains compliant with local, global, and regulatory guidelines. It involves periodic reviews of equipment, policies and procedures, gap analyses, and managing small- to mid-scale compliance projects. Responsibilities include conducting Historical Performance Reviews (HPR), identifying trends, reviewing equipment logbooks for adherence to regulatory policies, writing deviations and investigations, and contributing to internal audits and readiness. The role requires advanced knowledge of cGMP/GXP/GAMP, SDLC and 21 CFR Part 11, strong data presentation and communication skills, and the ability to work independently in a regulated environment. Proficiency with Microsoft Office and equipment data-quality systems is expected, along with experience in regulatory guidelines (FDA, EMA, USP, EP, JP) and a collaborative, team-oriented mindset.
Required Qualifications
- BS in Engineering or Science related discipline with minimum 4 years’ experience OR MS with 2 years’ experience in GMP environment/regulated industry
- 5-7 years’ experience in a pharmacopeia compliance related discipline preferred
- Working knowledge of regulatory guidelines such as FDA, EMA, USP, EP and JP
- Strong verbal and written communication skills, and the ability to work independently
- Must have strong interpersonal and communication skills, be a team player and be willing to work in an environment with initiative and accountability
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