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Compliance Specialist

3 months ago

Summit, United States On-Board Companies Full time
On-Board Scientific is hiring a Compliance Specialist based out of Summit, NJ (Hybrid)
For immediate consideration please send your resume to resumes@onboardusa.com
Subject Line: Position Title and State you are located.

About Us:
On-Board Services, Incorporated is an on-site contract service provider for a local manufacturing entity providing full time positions to our employees. We offer benefits as well as 401k.

Position Details:
Position Type: 1 year contract with additional opportunity contingent upon performance and continued business need
Job Location: Summit, NJ
Pay Rate: $58.61-$63.05 per hour.
Hybrid role

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.

Responsibilities:
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.
** Please note that this position is 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.

Qualifications
  • 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 is 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

On-Board was founded in 1976 by Robert L. Wilson to provide Engineering and Design services to the chemical manufacturing industry. Today, On-Board is a thriving privately held family of companies with services including: Consulting, Professional Engineering, Industrial Maintenance and Facility Management, Contracted Manufacturing and Production Services, as well as Temporary Staffing and Recruiting throughout North America.

The On-Board Family of Companies conducts operations through its Corporate Headquarters located in East Windsor, NJ along with Regional Offices in New Castle, DE and Wake Forest, NC. On-Board's Mission is to provide "Flexible Service by applying the talents of our people, work processes and technology to meet our clients' expectations in a Safe, Responsible and Dependable manner."

All candidates must complete background and drug screenings prior to start.

On-Board Companies provides equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability or genetics.

INDOJ
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