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18 days old

QCAnalyst/Sr. Quality Control Analyst

Kelly Services
Tustin, CA 92781
**QC Analyst/Sr. Quality Control Analyst**


**Tustin, CA**


**Direct-Hire**


**Job Description:**


The Analyst/Sr. Quality Control Analyst will perform testing and sampling to support manufacturing, validation, process development and stability studies in a GMP environment. This position requires a strong background in HPLC and supports/leads continuous improvement initiatives. This role is located in Tustin, CA and has a schedule of Mon-Fri 8 AM - 5 PM. This is a direct-hire opportunity.


**Essential Functions:**


+ Perform and review routine assays for HPLC and CE with strict adherence to written analytical test procedures.

+ Perform aseptic sampling, visual inspection, gowning and working in clean room areas, 5S methodology

+ Review, revise and write test methods, standard operating procedures and may perform trending analysis. In addition to performing QC testing, the Analyst may be designated as study Lead for validation projects, investigations and method development projects.

+ Other functions include but are not limited to: writing study protocols and reports; training other analysts; working with other departments in developing, revising and implementing QC procedures and policies.

+ Knowledgeable of company cGMPs as well as industry regulations that apply to all job functions.

+ Participate in regulatory inspections to ensure Laboratory is in Compliance with current Good Manufacturing Practices

+ Demonstrate and provide evidence to FDA official that the laboratory operations conforms to code of federal regulation.

+ Support continuous improvement initiatives by ensuring training relating to test methods, standard operating procedures, are up to date to comply with current good manufacturing practices.

+ Utilize Instruments software to perform calculations to minimize errors and eliminate time allocation for manual calculations.


**Required Education and Experience:**


For the Sr. Analyst level, a requirement of:


+ BS in Chem/Bio or related field plus 4-5 years industry experience in a QC or analytical lab, or equivalent combination of education/experience.


For the Analyst level, a requirement of:


+ BS in Chem/Bio or related field plus 2-4 years industry experience in a QC or analytical lab, or equivalent combination of education/experience.


Both positions require


+ Strong HPLC, Analytical Biochemistry and Chemistry experience.

+ Must also have experience with most if not all of the following: protein characterization, electrophoresis, chromatography (normal phase, reverse phase, size exclusion, ion exchange, etc), aseptic techniques, assay and validation/qualification.

+ Experience with analytical testing and equipment, writing reports/procedures/specifications, GMPs and regulatory audits are essential.


**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: 2021-10-01 Expires: 2021-11-01

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QCAnalyst/Sr. Quality Control Analyst

Kelly Services
Tustin, CA 92781

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