What are the responsibilities and job description for the Compliance Specialist position at Confidential?
Job Title: Compliance Specialist ******Contract Type: W2*****
Location: West, New Jersey, USA
Contract Duration: 12 Months
Work Hours: 40 hours per week
Job Summary:
The Compliance Specialist, Equipment Commissioning & Qualification (ECQ), supports the successful operation of facility, laboratory, and business functions at multi-use sites. This role involves interaction with internal team members, peer-level customers, and external service providers. The position ensures the compliance of equipment and the ECQ group with local, global, and regulatory guidelines.
Key Responsibilities:
- Historical Performance Review:
- Execute periodic reviews of equipment performance and use.
- Compile and analyze data to identify trends indicating equipment failure or deviation.
- Review logbooks, procedures, and usage for adherence to policies and guidelines.
- Identify necessary actions from findings, document deviations, and track recommendations.
- Departmental Compliance:
- Update and ensure departmental procedures align with local, global, and regulatory guidelines.
- Participate in the revision of departmental procedures to maintain compliance.
- Compliance Projects:
- Identify and scope small to large compliance projects.
- Lead compliance initiatives to maintain equipment or departmental standards.
- Equipment Compliance:
- Review new and existing equipment for regulatory compliance.
- Conduct gap analysis and provide guidance when changes are needed.
- Regulatory Support:
- Assist in preparing for internal and external audits.
Qualifications:
- Bachelor’s degree in Engineering or Science with a minimum of 4 years of experience, or Master’s degree with 2 years of experience in a GMP/regulated industry.
- Advanced knowledge of cGMP, GXP, GAMP, SDLC regulations, including 21CFR part 11.
- Experience with pharmaceutical, manufacturing, and laboratory systems and equipment.
- Strong analytical, organizational, and communication skills.
- Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook).
- Ability to multitask and manage various assignments efficiently.
- Pharma or biotech experience is required.
