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QA Compliance Associate

Company: Kaztronix
Location: New Brunswick
Posted on: November 18, 2022

Job Description:

Responsible for QMS Track wise module related to Laboratory, Investigation Review Board and Quality Review
Board -.
-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 21s -t -Centur -y Quality Initiatives
-Create prog -ress report on all projects under 21s -t -Cent -ury 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 21s -t -Century Quality program lead (Center of Excellence - member)
-Analytical methods and specification review in DCM and SOP review in EDMS.

Working in Manufacturing Environment, Laboratory Environment

Edu -cation and Job Qualification

-Minimum of Bachelor's degree.
-Excellent interpersonal and communication, both written and verbal, skills.
-Strong organizational and time management skills; must be ab -le to pr -ioritize 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.
-The requirement for English language proficiency for this job role is Intermediate-B1+ (comparable to Global
CEFR Independent B1) level based on the Common European Framework of Reference for Languages (CEFR).

Expe -rience

-Minimum of eight (8) years of experience within the pharmaceutical industry in quality function role.
-Experience working in an international multicultural matrix organization.

Keywords: Kaztronix, New Brunswick , QA Compliance Associate, Other , New Brunswick, New Jersey

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