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27 days old

Quality Assurance Associate Level II (direct hire)

Kelly Services
Allendale, NJ 07401
**Quality Assurance Associate Level II (direct hire)**


**Overview:** Kelly Services is seeking several motivated, enthusiastic individuals to join our clients team as Quality Assurance Associates. These are direct hire positions based in Allendale, NJ for a leader in cell and gene therapy. There are multiple shifts & schedules. Please indicate your preference when applying.


**Shifts available** : 1 st (7 or 7:30 am start) or 2 nd (2 or 2:30 pm start), Sunday through Wednesday or Wednesday through Saturday, i.e. 4 work days @ 10 hours per day. Please note that the weekend hours will be paid at 1.5 times the regular rate.


QA Associate II is responsible to perform Quality Assurance activities under direct supervision of daily tasks in support of Quality Systems and/or client procedures including but not limited to document management, review of QC data, material releases and final product releases as well as assisting Quality management with department needs.


**Essential Functions and Responsibilities:**


- Ensures that all procedures and processes meet internal quality standards as well as external regulations specific to pre-clinical, clinical and commercial manufacturing.


- Read, understand and follow all cGMP and cGTP documentation for Quality System Functions (SOPs,WIs,etc.)


- Maintain cGMP and cGTP compliance for all aspects of pre-clinical, clinical and commercial manufacturing.


- Release raw material in ERP system as well as on paper.


- Perform Accessioning of incoming Apheresis.


- Review Batch record and disposition material of finished product to client.


- Provides information for Out of Specification and deviations to investigator.


- Performs line clearance prior to manufacturing operations begins.


- Supports tech transfer activities.


**Required Skills & Qualifications:**


- BS or higher education degree in a scientifically related field


- Experience in a biologics or biotechnology company (1 -3 years)


- Working knowledge and technical understanding of the aseptic manufacture of biologics preferred


- Working knowledge of GMP and TCTP regulations


- Experience in reviewing GMP/GCTP related documents (validations/qualifications reports, SOPs, etc)



Please note that resumes from third parties will not be accepted. All candidates must be presently authorized to work for any employer in the US.


Apply today for immediate consideration or send your resume directly to


**Marina.Hart@kellyscientific.com**


**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: 2021-09-20 Expires: 2021-10-21

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Quality Assurance Associate Level II (direct hire)

Kelly Services
Allendale, NJ 07401

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