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10 days old

QC Analyst II/ Senior QC Analyst

Kelly Services
Richmond, CA 94802
QC Analyst II / Senior QC Analyst


Richmond, CA


Direct-Hire


Job Description:


The QC Analyst is responsible for the qualification and execution of analytical laboratory tests and evaluations of product performance and processes in the Quality Control Department, in accordance with approved methodologies, policies, and associated regulations. This is a full-time, direct-hire role, Mon-Fri during normal working hours.


Essential Responsibilities:


+ Perform and review assays, under minimal supervision, for protein and wet chemistry tests including but not limited to: pH, conductivity, TOC, Osmolality, UV-VIS, HPLC, Capillary Isoelectric Focusing, SDS-PAGE, qPCR, ELISA, etc.

+ Comply with cGMPs, SOPs, GLPs, safety requirements, and all company policies.

+ Write and revise SOPs, technical protocols, and reports.

+ Perform validations, studies, or transfers of new analytical methods and modifications to current methods in accordance with applicable policies or guidelines.

+ Generate highly compliant and reliable test results via documentation and by following cGMP principles. Train and mentor other analysts in the quality control department, such as performing laboratory procedures and assays.

+ Evaluate test data against defined criteria and specifications.

+ Identify and troubleshoot equipment and method issues.

+ Participate in out-of-specification and failure investigations and recommend corrective actions.

+ Work with the quality control management team to continuously improve the quality, compliance and efficiency of QC operations.

+ Maintain PM Preventative Maintenance for laboratory equipment.

+ Establish and maintain a safe and inspection-ready laboratory working environment.


Preferred Qualifications:


+ Minimum of BS/BA degree and 5 years working in a cGMP environment.

+ Bioassay and cell based assay experience.

+ Experience working in a Quality Control work environment, preferably in the pharmaceutical industry with knowledge of cGMPs or ISO regulations is desired.

+ Familiarity with relevant and current FDA, USP, EP, 21CFR, ICH guidelines and regulations.

+ Demonstrated knowledge of method development and qualifications. Strong technical writing and analytical skills.

+ Excellent written, verbal, communication and interpersonal skills.


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

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QC Analyst II/ Senior QC Analyst

Kelly Services
Richmond, CA 94802

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