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Quality Manager III
Ref No.: 18-08765
Location: Raritan, New Jersey
Business Quality Manager II
Raritan, NJ
6+ Month Contract

The purpose of this position is to support quality activities for Business Quality including product quality complaints, change control, internal audit/ supplier audits.

1. Process day-to-day product quality complaint (PQC) in Trackwise system including evaluating PQC, assigning investigation, conducting investigation, writing investigation summary. Proactively manage PQCs workflow with stakeholders to ensure all investigations are completed in a timely manner. (25%)
2. Create query and report of PQCs from Trackwise for all products and provide in-depth data analysis of complaint information and trending. Review medical information requests from database and provide in-depth data analysis (25%)
3. Process day-to-day change control records in Trackwise system (25%)
4. Coordinate internal and/or supplier audits including setting up logistic / preparation for the audits, drafting audit plan, supporting audit execution, coordinating audit response and CAPA with stakeholders, creating and documenting audit records in Trackwise system. Ensure all audit commitments are delivered on time (25%)

Required: BA/BS – Technical / Life Science
At least 4 to 5 years' experience in the Pharmaceutical or related industry;
Up-to-date knowledge of relevant pharmaceutical legislation and GMP/GDP
Experience working in the quality organization

Volume or unit measure of job duties:
20 PQCs / month
15 change control/ month

Equipment usage and abilities needed:
Highly experienced in Trackwise system, generating query and report, and data analysis with Excel spreadsheet