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18 days old

Quality Assurance Manager

Kelly Services
Titusville, NJ 08560
Kelly is hiring a **Quality Assurance Manager** for one of our clients in **Titusville**

**NJ.**


+ 1 year contract

+ pay: negotiable


**Job Description**


Provide support to Business Quality for Quality Systems, including Product Quality Complaint investigations and support for Controlled Substances.


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


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%)


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%)


Process day-to-day change control records in Trackwise system (25%)


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%).


Qualifications: 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


**Why Kelly** **** **?**


Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.


**About Kelly** ****


At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)
Posted: 2021-03-31 Expires: 2021-05-01

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Quality Assurance Manager

Kelly Services
Titusville, NJ 08560

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