COMPLIANCE SPECIALIST at HAYS in Princeton, New Jersey

Job Description:

The final salary or hourly wage, as applicable, paid to each candidate/applicant for this position is ultimately dependent on a variety of factors, including, but not limited to, the candidate's/applicant's qualifications, skills, and level of experience as well as the geographical location of the position.


Applicants must be legally authorized to work in the United States. Sponsorship not available.


Our client is seeking a COMPLIANCE SPECIALIST in Princeton, NJ.


Role Description


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.


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:
• 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


Benefits/Other Compensation


This position is a contract/temporary role where Hays offers you the opportunity to enroll in full medical benefits, dental benefits, vision benefits, 401K and Life Insurance ($20,000 benefit).


Why Hays?


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.


Nervous about an upcoming interview? Unsure how to write a new resume?


Visit the Hays Career Advice section to learn top tips to help you stand out from the crowd when job hunting.


Hays is committed to building a thriving culture of diversity that embraces people with different backgrounds, perspectives, and experiences. We believe that the more inclusive we are, the better we serve our candidates, clients, and employees. We are an equal employment opportunity employer, and we comply with all applicable laws prohibiting discrimination based on race, color, creed, sex (including pregnancy, sexual orientation, or gender identity), age, national origin or ancestry, physical or mental disability, veteran status, marital status, genetic information, HIV-positive status, as well as any other characteristic protected by federal, state, or local law. One of Hays' guiding principles is 'do the right thing'.
We also believe that actions speak louder than words.
In that regard, we train our staff on ensuring inclusivity throughout the entire recruitment process and counsel our clients on these principles. If you have any questions about Hays or any of our processes, please contact us.


In accordance with applicable federal, state, and local law protecting qualified individuals with known disabilities, Hays 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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#1169926 - Michal Mercier