QC Associate

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Job description

**QC Associate**

**Temp-to-Hire**

**San Diego, CA**

**Job Description:**

The Quality Control Associate will be responsible for performing multiple tasks within the Quality Control group in support of GMP large-molecule manufacturing activities. Focus areas include routine analytical testing and documentation/data review of QC generated results. May include execution of method qualification, transfer or validation activities.

**Essential Duties:**

+ Performs timely and accurate analytical testing of in-process, release and stability samples and raw material testing samples

+ Provides review of QC data and associated documentation

+ Supports laboratory investigations to determine root cause for OOS and invalid test results

+ Executes qualification/validation protocols and writes technically sound qualification/validation reports

+ Contributes to laboratory operations by performing regular instrument calibration and minor instrument maintenance

+ Maintains logs and related documentation with accuracy using GDP

**Qualifications/Skills Required:**

+ Minimum of B.S. degree in a scientific discipline with 6 months - 7 years of relevant Quality Control industry experience in a GMP environment

+ Knowledge of compendial tests such as pH, conductivity, osmolality

+ Knowledge of the theoretical and practical aspects of analytical methods utilized to characterize large molecule therapeutics including: U/HPLC, CE, cIEF, ELISA, and SDS PAGE

+ Experience with the transfer and qualification/validation of large molecule focused analytical methods is a plus

+ Experience with preparing QC documents such as notebooks, forms, reports and reviewing QC data

+ Demonstrated understanding of USP, EP and ICH guidelines

+ Strong written and oral communication skills, proficient with Microsoft Office software

**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 interests-it's 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, we're always thinking about what's next and advising job seekers on new ways of working to reach their full potential. In fact, we're 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. ()