The end client is unable to sponsor or transfer visas for this position; all parties authorized to work in the US without sponsorship are encouraged to apply.
An American Company is seeking a Compliance Specialist in Princeton. NJ.
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.
Skills & Requirements
• 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:
• 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.
You will be working with a professional recruiter who has intimate knowledge of the industry and market trends. Your Hays recruiter will lead you through a thorough screening process in order to understand your skills, experience, needs, and drivers. You will also get support on resume writing, interview tips, and career planning, so when there's a position you really want, you're fully prepared to get it.
Additionally, this position is a contract role where Hays offers you the opportunity to enroll in full medical, dental or vision benefits.
• Life Insurance ($20,000 benefit)
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Hays is an Equal Opportunity Employer including disability/veteran.
In accordance with applicable federal and state law protecting qualified individuals with known disabilities, Hays U.S. Corporation will attempt to reasonably accommodate those individuals unless doing so would create an undue hardship on the company. Any qualified applicant or consultant with a disability who requires an accommodation in order to perform the essential functions of the job should call or text 813.336.5570
Drug testing may be required; please contact a recruiter for more information.
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