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Associate II, Compliance - QA

New Brunswick, New Jersey · Biotech/Pharmaceutical

Are you looking to be a part of a premier pharmaceutical company? One of our largest clients is currently seeking an Associate II, Compliance - QA to join their New Brunswick, New Jersey team. Our client is one of the leading pharmaceutical companies specializing in developing and manufacturing of solid dosage products. If you believe you are qualified, we would be excited to connect and discuss this opportunity in more detail.

Please visit us at https://www.prostaffworkforce.com/ to explore all opportunities.

Direct Hire
Pay Rate: DoE

Job Summary:
Responsible for QMS Trackwise module related to Laboratory, Investigation Review Board and Quality Review Board.

Area of Responsibility:
· Review of all investigations related to QC Lab and CFT Investigations.
· Ensure investigations are properly reviewed with respect to root cause, CAPA requirements and their evaluation.
· Conduct IRB & QRB meetings as per schedule.
· Create database for all IRB and QRB meeting information; track action items and ensure the actions are completed.
· Track all overdue records impacting the QRB Site Quality Index.
· As per schedule generate IRB & QRB reports and submit on a timely basis to Corporate Function.
· Develop an action plan for investigation improvements and Site Quality Index
· Work closely on all projects under 21st Century Quality Initiatives
· Create progress report on all projects under 21st Century Quality Initiatives.
· Provide information for product assessment report, analytical life cycle activity and QMMR.
· Review product related changes, if any.
· Review Track wise records for QA related activities such as UPD / Lab event / OOS / OOT / change control / CAPA and verification of action items
· Investigation certification module for the site, provide data for Investigation effectiveness checks.
· Investigation effectiveness check.
· Work as 21st Century Quality program lead (Center of Excellence - member)
· Analytical methods and specification review in DCM and SOP review in EDMS.


Requirements:
· Minimum of Bachelor’s degree.
· Minimum of eight (8) years of experience within the pharmaceutical industry in quality function role.
· Experience working in an international multicultural matrix organization.
· Excellent interpersonal and communication, both written and verbal, skills.
· Strong organizational and time management skills; must be able to prioritize and manage multiple
assignments simultaneously while working independently or with others as needed.

· A self-starter with a hands-on approach and a can-do attitude.



Our client offers a competitive compensation package as well as an excellent benefits package for eligible candidates.



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