Compliance Specialist

Compliance Specialist

Location: Summit, NJ

Duration: 12 months (possibility of extension for the right candidate depending on performance)

Work Schedule: Flexible to come onsite a minimum of 50% as required by the manager

Must Haves:

• Bachelor's degree required
• Advanced knowledge of cGMP, GXP, GAMP, SDLC regulations, including 21 CFR Part 11, computer systems validation requirements, and good documentation practices
• Advanced knowledge of pharmaceutical, manufacturing, and laboratory systems and equipment

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, peer-level customers, and 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. They will perform periodic reviews of equipment, policies and procedures, conduct gap analysis where required, and manage small-scale projects to complete departmental objectives.

Required Competencies - Knowledge, Skills, and Abilities

• Advanced knowledge of cGMP, GXP, GAMP, SDLC regulations, including 21 CFR Part 11, computer systems validation requirements, and good documentation practices.
• Advanced knowledge of pharmaceutical, manufacturing, and laboratory systems and equipment.
• Strong attention to detail.
• Strong written and verbal communication skills.
• Excellent interpersonal skills with experience dealing with a diverse workforce.
• Strong multitasking ability and proven organizational skills.
• Ability to organize assigned tasks in a high-paced environment and concurrently monitor tasks/assignments with others that may impact timely completion.
• Ability to effectively manage multiple tasks and activities simultaneously.
• Strong presentation development and delivery skills.
• Highly proficient computer skills in Microsoft Office Suite – Word, Excel, PowerPoint, and Outlook, with extensive background in database systems.
• Ability to quickly learn new software such as corporate intranet and enterprise business systems.
• Ability to organize and present data and findings clearly.
• Experience with investigations.

Education and Experience

• Required: BS in Engineering or Science-related discipline with a minimum of 4 years of experience OR MS with 2 years of experience in a GMP environment/regulated industry.
• 5-7 years' experience in a pharmacopeia compliance-related discipline preferred.
• 5-7 years of experience 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.

Duties and Responsibilities

1) Historical Performance Review

• Execute the Historical Performance Review (HPR), a periodic review of equipment performance and use.
• Compile data from HPR and analyze trends to identify equipment failures or out-of-trend issues.
• Review equipment logbooks, procedures, and use for adherence to local, global, and regulatory policies, procedures, and guidelines.
• Identify and recommend actions based on HPR findings.
• Write deviations and perform investigations per internal procedures.
• 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 the latest versions of local, global, and regulatory policies, procedures, and guidelines.

3) Compliance Projects

• Identify and scope projects of small and large complexity required to maintain equipment or department compliance.
• Lead small and large-scale projects to maintain compliance.

4) Ensure Equipment Compliance

• Receive and review revisions to USP, EP, JP, and 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 upon arrival to ensure compliance.

5) Regulatory Responsibilities

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

Working Conditions (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 the workspace for extended periods.
• Ability to perform repetitive tasks including hand-to-finger manipulations, grasping, pushing, and pulling.

Environmental Conditions

• Primarily office environment but will be required to enter laboratory or GMP process areas wearing proper gowning/lab coats or PPE such as safety glasses and shoes.
• Ability to work safely and effectively when working alone or with others.