Compliance Specialist-Risk Management
Newark Metro Area, NJ
1) Historical Performance Review:
a. Execute the historical performance review (HPR), a bi annual review of equipment performance and use.
b. Compile data gathered from HPR and use to analyze trends that could show equipment failure or out of trend.
c. Review equipment logbooks, procedures and use for adherence to local, global and regulatory policies, procedures and guidelines.
d. Identify and recommend actions to take as a result of the completed HPR.
2) Ensure ECQ Departmental Compliance:
a. Participate in revisions to departmental procedures to ensure compliance.
b. Ensure departmental procedures and policies comply with latest versions of local, global and regulatory policies, procedures and guidelines.
3) Compliance Projects:
a. Through job functions listed above identify and scope projects of small and large complexity required to keep equipment or the department in compliance.
b. Lead projects both small and large in scope required to keep equipment or the department in compliance.
Advanced knowledge of cGMP, GXP, GAMP, SDLC regulations, including 21CFR part 11, computer systems validation requirements and good documentation practices.
Advanced knowledge of pharmaceutical, manufacturing and laboratory systems and equipment.
Highly proficient computer skills in Microsoft Office Suite Word, Excel, PowerPoint and Outlook with extensive background in database systems. Innate ability to learn new software, such as corporate intranet and enterprise business.
Education & Experience:
BS in Engineering or Science related discipline.
Minimum 5 years experience in GMP environment / regulated industr.y
2-3 years experience in a pharmacopeia compliance related discipline preferred.
2-3 year' 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.