Job Title: Compliance Specialist
Location: Summit, NJ (Hybrid)
Duration: 12 Months with Possible Extension
Job Summary:
- We are seeking a Compliance Specialist to join our team in Summit, NJ. This role ensures adherence to regulatory requirements, manages equipment compliance, and supports audit preparations. If you have expertise in cGMP, GXP, GAMP, and regulatory compliance, this is an excellent opportunity to contribute to a dynamic and fast-paced environment.
Job Responsibilities:
- Execute and analyze the historical performance review (HPR) of equipment performance and use.
- Participate in revisions to departmental procedures to ensure compliance.
- Lead small and large-scale projects to maintain equipment and departmental compliance.
- Review and provide guidance on revisions to regulatory guidelines.
- Assist in the preparation for both internal and external audits.
Skills Required:
- Advanced knowledge of cGMP, GXP, GAMP, SDLC regulations, including 21CFR part 11, computer systems validation requirements, and good documentation practices.
- Proficiency in pharmaceutical, manufacturing, and laboratory systems and equipment.
- Excellent written and verbal communication skills with strong attention to detail.
- Ability to multitask and manage multiple tasks and activities simultaneously.
- Proficient computer skills in Microsoft Office Suite and database systems.
- BS in Engineering or Science-related discipline with minimum 4 years’ experience or MS with 2 years’ experience in a GMP environment/regulated industry.
About SSi People:
With over 26 years of industry experience, SSi People has built its reputation and expertise on putting people first. Everything we do works toward delivering an exceptional experience for our consultants, our clients, and our internal team. Through a genuine commitment to people in everything we do. We have developed refined processes and a stellar internal team to deliver talent quickly. More importantly, we focus on building long-term relationships, not transactions. Putting people first is just what we do well.
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