NewBrunswickRecruiter Since 2001
the smart solution for New Brunswick jobs

Sr Specialist / Specialist / Associate II, Compliance

Company: ProStaff Solutions Inc
Location: New Brunswick
Posted on: June 11, 2022

Job Description:

ProStaff Solutions is looking for Sr QC Compliance Specialist and QC Compliance Specialist to work with a pharmaceutical company in New Brunswick, NJ. Direct Hire Job Summary for Sr QC Compliance Specialist: Independently manages laboratory compliance activities for assigned functions and projects. Author Laboratory method, specification. Perform and write laboratory, CAPAs, Lab Event/Out-of-Specification and Out-of-Trend investigations, deviations. Author laboratory SOP's accordingly to company's standards and FDA /ICH guidelines. Job Summary for QC Compliance Specialist: Under limited supervision, manages laboratory compliance activities for assigned functions and projects. Investigates method performance, reliability and improvement issues, and evaluates proposed changes to compendial or in-house methods. Prepare and review the technical and compliance documents such as analytical methods, specifications, Method Validation/Transfer Protocols and Reports, SOP's accordingly to company's standards and FDA /ICH guidelines, CAPAs, Lab Event/Out-of-Specification and Out-of-Trend investigations. To review the USP and other compendia changes on a timely basis and update the related documents to implement the changes and ensure the compliance. Required Qualifications: Minimum BS or equivalent degree in Chemistry or related discipline. Minimum of eight (8) years of experience in the pharmaceutical industry. (Sr Specialist) Minimum of four (4) years of experience in the pharmaceutical industry. (Specialist) Must have an understanding of FDA guidelines, ICH guidance and DEA regulations. Ensures compliance with cGMPs, DEA regulations, safety and site operating procedures under the direction of Management. Must be familiar with proper cGMP practices for analytical laboratories and working knowledge of basic laboratory instrumental analysis and wet chemistry skills. Must have cGMP compliance knowledge and experience. Collaborates with colleagues and external partners to achieve primary Department goals. Works in coordination with project plans and goals as assigned by Management. Demonstrated excellent communication: verbal, written and presentation skills. A self-starter with a hands-on approach and a can-do attitude. A team building champion driving innovative cross functional synergies. Excellent computer skills, and competence with Microsoft Office (Word, Excel, PowerPoint) and Access. Excellent project management and problem solving skills.

Keywords: ProStaff Solutions Inc, New Brunswick , Sr Specialist / Specialist / Associate II, Compliance, Other , New Brunswick, New Jersey

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category
within


Log In or Create An Account

Get the latest New Jersey jobs by following @recnetNJ on Twitter!

New Brunswick RSS job feeds