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Compliance Specialist

Summit, NJ 07901

Posted: 07/06/2023 Job Number: 24402088

Job Description

100% Onsite.
Pay ranges between $56.67- $59.91/hr.

Required Skills:
  • 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.
  • 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.
  • 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.

Project Description:
  • 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.
  • 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.
  • 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.

This 6+ month position starts ASAP.

Please E-MAIL your resume (attachment to email) with rate and availability to Loren: loren@alphaconsulting.Com



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Loren Graham

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