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27 days old

GMP Quality Operations Specialist - Direct Hire

Kelly Services
Eden Prairie, MN 55344
**Quality Operations Specialist**


+ Eden Prairie, MN

+ Direct Hire

+ Mon-Fri 1 st shift

+ Compensation: 50-60k/year


**Primary duties include:**


+ Environmental monitoring by performing and reading touch plates, maintaining and reporting data, and tracking trends.

+ Managing the DI water system by coordinating maintenance, performing monthly sanitization, and collecting water samples.

+ Maintaining the document control system and authoring controlled documents related to job functions.

+ Maintaining the equipment management system and ensuring all equipment is calibrated and in good working order.

+ Review manufacturing, environmental monitoring and quality control data for in-process and finished products.

+ Monitor GMP activities sitewide to ensure compliance with applicable procedures and suitable regulatory requirements.

+ Perform material manufacturing batch record review and material release.

+ Provide Quality support for nonconformance investigation.

+ Perform various support functions to ensure that all requirements of the Quality Management System are met.


**Organizational Requirements:**


+ Must be willing and able to respond to changing priorities and handle changing workflow.

+ Demonstrates working knowledge of current Good Manufacturing Practices (GMPs)

+ Works directly with operating entities and internal GMP clients with assistance from management to ensure follow-up of quality issues.

+ Has previous working experience with manufacturing operations and associated support functions (Cell biology/Micro/Facilities)


**Required Qualifications:**


+ BA/BS in biology, microbiology, biomedical engineering, or related field.

+ 4+ years of QA work experience in a GMP setting preferred

+ Excellent organizational, verbal, written and interpersonal skills are essential, as well as enthusiasm for a collaborative work culture.

+ Must be able to accommodate scheduling adjustments, off-shifts, holiday, and weekend work assignments if needed.

+ Attention to detail is essential.


**Preferred Qualifications:**


+ Preference given to candidates with prior Biopharmaceutical (biological products) industry or FDA controlled environments. Experience with cGMP, environmental monitoring, equipment management, document control, and technical writing.


**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)

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Posted: 2021-04-16 Expires: 2021-05-17

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GMP Quality Operations Specialist - Direct Hire

Kelly Services
Eden Prairie, MN 55344

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