Compliance Specialist

19 Nov 2024

Vacancy expired!

Title: Compliance Specialist Location: Summit, NJStart date: ASAPResponsibilities: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.

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.

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.

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.

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.

Assist in the preparation for both internal and external audits.

Requirements:BS in Engineering or Science related discipline.

Minimum 5 years’ experience in GMP environment / regulated industry.

2-3 years’ experience in a pharmacopeia compliance related discipline preferred.

2-3 year' 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

Joule, a System One division is a leader in specialized workforce solutions and integrated services. With more than 6,000 employees and roughly 50 offices throughout the U.S. we provide scientific, clinical, engineering, energy, IT, legal and administrative staffing services. For more than 40 years, we have delivered workforce solutions and integrated services to clients nationally.System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible full-time employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.

Full-time
  • ID: #23014439
  • State: New Jersey Summit 07901 Summit USA
  • City: Summit
  • Salary: USD TBD TBD
  • Showed: 2021-11-19
  • Deadline: 2022-01-18
  • Category: Et cetera