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17 days old

GMP Sr. Specialist, Quality Assurance, Irvine, CA

Kelly Services
Tustin, CA 92781
**GMP Sr. Specialist, Quality Assurance, Irvine, CA**



**Summary:** The Sr. Quality Assurance Specialist is an individual contributor who solves a variety of issues following cGMP regulations and company standards.



**Essential Duties and Responsibilities:**




+ Coordinate the release of API batches and lots.

+ Release of Manufacturing Buffers and Formulations.

+ Assist with discrepancy investigations.

+ Review of **Manufacturing Batch Production Records** - Must have at least 4 years or more experience.

+ Sign documents for activities as authorized and described by company policies, procedures and job descriptions.

+ Collaborate with departments to ensure that all review activities are executed efficiently per governing SOPs.

+ Serve as a technical subject matter expert (SME) in support of department functions.

+ Review of testing documentation from Microbiology and Chemistry groups.

+ Compilation and QA Review of all records in Batch history records.

+ Issue, verify and file documents relating to processes, equipment, facilities and utilities in the manufacture of product.



**Qualifications:**




+ B.S. degree in a Science discipline.

+ Require a minimum 4-6 years of experience in Manufacturing Batch Production Records review.

+ Must be able to interpret Quality standards for implementation.

+ Must have flexibility in problem solving and work hours to meet business objectives.

+ Require the ability to communicate clearly and professionally both in writing and verbally.

+ Skills to independently evaluate situations and propose potential solutions are essential.

+ Knowledge of cGMPs or equivalent regulations is preferred.

+ Industry experience working for a Contract Development and Manufacturing Organization (CDMO) is highly desirable.



**For Immediate Consideration, Apply Today! Questions? Call Grace at 714.253.7656 or schedule a time to connect directly follow the link:** https://calendly.com/gracepiper/15min-1




**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/non-traditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. 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 and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Kelly will work with applicants to meet accommodation needs that are made known to Kelly in advance.
Posted: 2020-10-12 Expires: 2020-11-12

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GMP Sr. Specialist, Quality Assurance, Irvine, CA

Kelly Services
Tustin, CA 92781

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