25 days old

Quality Assurance Associate III (Biologics/Biotech)

Kelly Services
Allendale, NJ 07401
**Quality Assurance Associate III**

Allendale, NJ

Direct-Hire Opportunity

Monday-Friday, 8AM-5PM or 12PM-8PM

**Kelly Science & Clinical is interviewing and hiring immediately for a Quality Assurance Associate!** This is a direct-hire opportunity with a leader in gene and cell therapy field.

**Overview:** This position is responsible for performing Quality Assurance activities including but not limited to document management, issuance, review and approval of batch records, SOPs, Qualification and Validation Reports; review of QC data; perform material releases and final product releases; review of Deviations as well as assists Quality management with department needs.


+ Schedules batch record process for all floor associates in accordance with kitting schedule.

+ Facilitates internal training on quality assurance requirements, processes, and procedures.

+ Provides technical expertise to the client services team on tech transfer activities.

+ Provides supportive documents to investigators and/or compliance team.

+ Conducts final verification of batch records prior to archiving; sends records to document control; Review of executed APS reports/ batch records.

+ Draft SOPs, WIs, and Forms for revision.

+ Supports QA teams with continuous improvements initiatives to enforce quality culture.

+ Initiate change control as required.

+ Assist gathering information for internal and external (e.g. cGMP, client, regulatory agencies) audits.

+ Support walk-thru in preparation for internal and external (e.g. cGMP, client, regulatory agencies) audits.

+ Other duties as assigned.


+ Bachelors degree in science or related field **required**

+ Minimum 5 years of experience in QA in a life sciences company with a strong focus in the manufacturing and/or testing of biologics

+ 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)

+ Experience in both clinical and commercial manufacturing is preferred.

+ Experience in authoring, reviewing, and /or approving cGMP/cGTP related documents (validation/qualification reports, SOPS. Etc.

+ Experience in organizing teams for effective and timely completion of projects.

+ Understanding of quality system applications, including the use of electronic applications for training, deviations, CAPA management, etc.

+ Experience participating in or hosting health authority inspections and/or client audits.

+ Must be able to work during the weekend, holidays and as required by the company

+ Must be able to handle the standard/moderate noise of the manufacturing facility

+ Must be physically capable to stand; walk; sit; bend; stretch; use hands and fingers, handle or feel; reach with hands and arms; and talk or hear.

**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. (
Posted: 2021-11-12 Expires: 2021-12-13

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Quality Assurance Associate III (Biologics/Biotech)

Kelly Services
Allendale, NJ 07401

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