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30 days old

Quality Assurance Specialist I/II

Kelly Services
Boulder, CO 80305
**Quality Assurance Specialist I/II - Line Operations**


**Direct Hire**


Salary


$47,000-$85,00K-DOE


2nd Shift


Sunday-Wednesday


4/10 hour shifts


2:30 PM-12:00 PM


**Job Description**


This position will provide a broad range of quality oversight for activities that support bulk drug substance manufacturing. Responsible for quality oversight of manufacturing floor operations, facility/utility qualification and maintenance oversight, and QC laboratory support. This position will be responsible for review and approval of procedures and methods supporting all aspects of GMP operations, including support of client and regulatory audits.


**Major Responsibilities:**


+ Performs compliance review on GMP records including:

+ Approves procedures, specifications, test methods, sampling plans, and forms which may impact material or product quality.

+ Approves changes, validation documents, and maintenance work plans.

+ Approves minor deviations and lab investigations.

+ Works directly with manufacturing, the laboratory and other departments responsible for GMP activities to resolve compliance issues in a timely manner.


**Experience:**


BS and 4+ years experience or MS and 2+ years experience in a GMP QA environment or equivalent. Inter and intra departmental project management experience and experience with electronic document management systems desired.


**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: 2021-05-24 Expires: 2021-07-24

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Quality Assurance Specialist I/II

Kelly Services
Boulder, CO 80305

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