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25 days old

QA Associate I (Stanford, CA)

Kelly Services
Palo Alto, CA 94301
Quality Assurance Associate I


Stanford, CA


Direct-Hire, Full-Benefits


Pay: Up to 73K plus bonus


**Job Description:**

The Quality Assurance Associate supports the implementation and maintenance of quality assurance processes and procedures for the Laboratory for Cell and Gene Medicine.


**Essential Duties:**


+ Assist with developing, drafting, maintaining, and compiling of process related documents to support cGMP (current Good Manufacturing Practice) clinical manufacturing.

+ Support with generating procedures by following set guidelines and provide suggestions for issues found in documentation processes.

+ Execute quality assurance operations required to assess, evaluate, and review processes against cGMPs.

+ Perform real-time observation of activities and issue identification/resolution including proper and timely documentation.

+ Identify, classify, and report deviations from the process and/or protocols to provide recommendations and process improvements to Process Development/ Manufacturing (PD/MFG) and Quality Control, to ensure compliance with all applicable regulations, and to assist in the resolution of issues.

+ Escalate critical issues within assigned area to senior management team based on severity of the issue.

+ In support of clinical trials, onsite production support, review batch records and product dispositions to ensure process is performed per procedure guidelines and address any deviations.

+ Assist with the development of standardizing processes for review and maintaining Standard Operating Procedure (SOPs), batch records, raw materials specifications, certificate of analysis, training records etc.

+ Support Materials Management activities such as receipt, inspection, and kitting.

+ Responsible for compiling, organizing and storing all documentation related to FDA and cGMP regulations including developing and maintaining a system for storing documents.

+ Provide support to cGMP compliance audits of vendors, contract manufacturers, contract laboratories and quality systems by preparing and reviewing all documents, tracking timelines, and handling back office operations during site visits.


**Desired Qualifications:**


+ Bachelors degree and 1-year relevant experience or an equivalent combination of education and relevant experience.

+ Knowledge of GMP compliance, and quality systems.

+ Applicable or related experience in a quality-related work in a pharmaceutical/medical device/biotechnology manufacturing setting

+ Ability to manage and coordinate all tasks assigned and effectively complete all expected deliverables in a timely manner and proactively communicate changes in pre-established goals and deadlines

+ Experience with office software and database applications.

+ Excellent inter-personal skills and customer service focus.

+ Ability to communicate effectively both orally and in writing


**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 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: 2022-06-03 Expires: 2022-07-04

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QA Associate I (Stanford, CA)

Kelly Services
Palo Alto, CA 94301

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