Quality Compliance Specialist

Purpose and Scope of the Position

• The Compliance Specialist, Equipment Commissioning & Qualification, supports the successful operation of facility, laboratory, and business functions at multi-use sites through interaction with internal team members and peer-level customers as well as external service providers.
• The incumbent in this individual contributor role ensures the compliance of equipment and the ECQ group with local, global, and regulatory guidelines.
• The incumbent will perform periodic reviews of equipment, policies and procedures, gap analysis where required, and small-scale projects to complete departmental objectives.

Required Competencies- Knowledge, skills, and abilities

• 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.
• Possess experience with investigation

Education and Experience:

• 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.

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.

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.

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.

Regulatory Responsibilities:

• Assist in the preparation for both internal and external audits.

Working Condition (US only):

Physical / Mental Demands:

• Occasional stooping, bending, stretching, pushing, pulling, reaching and/or lifting up to 25 lbs
• Ability to sit, stand, walk and move within workspace for extended periods
• Ability to perform repetitive tasks including hand to finger manipulations, grasping, pushing, and pulling.

Job Type: Contract

Salary: $42.46 - $58.00 per hour

Experience level:

• 5 years

Schedule:

• 8 hour shift
• Day shift
• Monday to Friday

Work setting:

• In-person

Ability to commute/relocate:

• Summit, NJ 07901: Reliably commute or planning to relocate before starting work (Required)

Education:

• Bachelor's (Preferred)

Experience:

• quality compliance: 5 years (Preferred)
• pharma industry: 5 years (Preferred)
• USP, EP, JP, FDA regulatory guidelines: 3 years (Preferred)
• pharmacopeia compliance: 5 years (Preferred)
• 21CFR part 11: 5 years (Preferred)
• cGMP, GXP, GAMP, SDLC regulations: 5 years (Preferred)
• investigation: 5 years (Preferred)

Work Location: One location

Salary : $42 - $58