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27 days old

Quality Assurance Specialist

Kelly Services
Osh Kosh, WI
Quality Assurance Specialist


fulltime position available in north Milwaukee Wisconsin


Manufacture products


Quality Assurance Engineer needed to assist with audits, supplier quality, planning and process validations


Direct Hire with benefits


Work day 8:00-5:00 pm with occasional overtime as needed


PRINCIPAL RESPONSIBILITIES:

1) Process various documents supporting the Quality Management System (QMS), such as: Non-Conformance (NC) Reports, Corrective and Preventive Actions (CPAs), Deviations/Waivers, Customer Complaints and Quality Alerts.

2) Use Root Cause Analysis to investigate and identify the true cause of NC product or processes, audit findings, etc. Based on the root cause, work as a team with various departments to create an action plan to prevent reoccurrence of issues.

3) Work with customers for approvals of CPAs, Deviations/Waivers, etc when necessary.

4) Conduct document reviews of various controlled documents to ensure processes are accurately being followed and/or need to be updated to reflect the actual process.

5) Act as a liaison and knowledge reference between Quality and various departments (i.e. Compounding, Filling, etc), to ensure procedures and specifications of various customers are being followed to produce product right first time.

6) Create and implement effective Control Plans for assigned products/processes.

7) Generate and/or edit controlled documents to ensure manufacturing processes are being followed in accordance with customer specifications, regulatory requirements, and established validation parameters.

8) Assist in conducting Annual Product Reviews (APRs) of regulated/drug products.


Minimum of Associate degree in Quality with a BA/BS degree in a field of science preferred -Lean Manufacturing and/or Six Sigma Green Belt preferred -Background in manufacturing, with cGMP and FDA compliance preferred


Accepting candidates for immediate interviews !


**You should know:** Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.


**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: 2021-11-05 Expires: 2021-12-20

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Quality Assurance Specialist

Kelly Services
Osh Kosh, WI

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