Job description

Title: Compliance Specialist Location: Summit, NJ Start date: ASAP Our client is looking for the following: Responsibilities: 1) Historical Performance Review: • Execute the historical performance review (HPR), a periodic review of equipment performance and use. • Compile data gathered from HPR and use to analyze trends that could show equipment failure or out of trend. • Review equipment logbooks, procedures and use for adherence to local, global and regulatory policies, procedures and guidelines. • Identify and recommend actions to take because of HPR findings. • Write deviation and perform investigation per internal procedure. • Track HPR recommendations and remediation actions. 2) Ensure ECQ Departmental Compliance: • Participate in revisions to departmental procedures to ensure compliance. • Ensure departmental procedures and policies comply with latest versions of local, global and regulatory policies, procedures and guidelines. 3) Compliance Projects: • Through job functions listed above identify and scope projects of small and large complexity required to keep equipment or the department in compliance. • Lead projects both small and large in scope required to keep equipment or the department in compliance. 4) Ensure Equipment Compliance: • Receive and review revisions to USP, EP, JP, FDA regulatory guidelines. Provide guidance to the team if changes are required. • Perform gap analysis on existing equipment and technologies to ensure compliance. • Review new equipment and technologies as it comes to site to ensure compliance. 5) Regulatory Responsibilities: • Assist in the preparation for both internal and external audits. With the following credentials: Requirements: Required BS in Engineering or Science related discipline w/minimum 8 years experience OR MS w/6 years experience in GMP environment/regulated industry • 5-7 years experience in a pharmacopeia compliance related discipline preferred. • 5-7 years' experience with troubleshooting complex laboratory equipment. • Working knowledge of regulatory guidelines such as FDA, EMA, USP, EP and JP. • Excellent computer skills including knowledge of equipment data quality systems. • 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 where individual initiative, accountability to the team, and professional maturity are required. System One offers eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

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