Job Title: Compliance Specialist
Duration: 12 Months
Location: Summit, NJ 07901
Work schedule: Need to be flexible to come onsite min 50% as required by manager

50% Onsite

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.
• Strong attention to detail.
• Strong written and verbal communication skills.
• Excellent interpersonal skills with experience dealing with a diverse workforce.
• Strong multi‐tasking ability in conjunction with 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. Innate ability to learn new software,
such as corporate intranet and enterprise business.
• Ability to organize and present data and findings clearly.
• Possess experience with investigation

Education and Experience:
• Required BS in Engineering or Science related discipline w/minimum 4 years’ experience OR MS w/2 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.

Duties and Responsibilities
1) Historical Performance Review:
• Execute the historical performance review (HPR), a periodic review of equipment performance and use.
• Compile data gathered from HPR and use to analyze trends that could show equipment failure or out of trend.
• Review equipment logbooks, procedures and use for adherence to local, global and regulatory policies, procedures and guidelines.
• Identify and recommend actions to take because of HPR findings.
• Write deviation and perform investigation per internal procedure.
• 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 latest versions of local, global and regulatory policies, procedures and guidelines.
3) 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.
4) 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.
5) 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.

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