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.
A Pharmaceutical Company is seeking a Document Coordinator in Princeton, NJ.
• Manages and executes the initiation, processing, routing, distribution and archiving of cGMP documentation.
• Manages the document change control process, coordinating cross functional reviews, approvals and effective dates in alignment with requirements and customer needs
• Serves as a subject matter expert for the electronic document management system.
• May assist in user training on the electronic document management system.
• Provides Records Management support during in regulatory agency inspections and corporate audits.
Skills & Requirements
• Minimum HS diploma with related experience required. B.S. degree (in Science, Engineering, Biochemistry) is preferred.
• A minimum of 2 years of relevant experience including a minimum of 1 year of direct document management experience in a regulated environment focused on product quality.
• Strong teamwork and communication skills and the ability to follow written and verbal instructions.
• Knowledge of biotech bulk and finished product manufacturing, analytical testing is highly desirable.
• Familiarity with US and EU cGMP regulations and guidance is required.
• Working knowledge of common computer systems such as MS-Word and Excel is required.
• Experience with electronic document management systems, is preferred.
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. #1143238