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14 days old

Quality Assurance Technician

Kelly Services
Manitowoc, WI 54221
**Entry Level Quality Assurance Technician (2 openings)**


**Manitowoc, WI**


**Direct Hire**


**Pay rate: $25/hr**


**Hours: 8am to 4:30pm**


The purpose of the Quality Assurance Technician is to help ensure all products produced by the client meets internal or external (i.e. customer or regulatory) requirements, that utilizes a broad scope to look at processes from dock-to-dock, to ensure those requirements are being met.


**EDUCATIONAL/TRAINING REQUIREMENTS**


+ 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

+ Proficient in Microsoft Word, Excel, and Outlook


**EXPERIENCE REQUIRED** :

None (College Grad); will train


**PRINCIPAL RESPONSIBILITIES:**



+ 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.

+ 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.

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

+ 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.

+ 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.

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

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

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

+ Provide support for external audits; process audit findings as requested by management.

+ Work with vendors on supplier quality issues as needed.

+ Conduct assigned process capability studies.

+ Work with customers to resolve discrepancies in specifications, processes, etc to ensure both parties are in agreement.

+ Assist in planning, executing, and managing of process validations (for Cleaning, Sanitizing, Blending, Filling, etc) following IQ/OQ/PQ format for regulated/drug products.

+ Work with customers as a cross-functional team to create peer reviewed validation protocols and reports.

+ Perform other duties as required or requested by management.


**Additional Detail:**


+ **As your local offices do not support this position, for immediate consideration, please apply online to this posting directly.**

+ **Resumes in MS Word are preferred.**

+ **If you have questions about the position, you may contact the recruiter at** **Leslie.Hesano@kellyservices.com** **; however, your resume must be received via the official posting.**


**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: 2021-06-07 Expires: 2021-07-08

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Quality Assurance Technician

Kelly Services
Manitowoc, WI 54221

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