QA Specialist Job Listing at Kelly Services in New Brunswick, NJ (Job ID 9423715)

Description

Kelly is hiring for a QA Specialist position with one of our clients in New Brunswick, NJ.
 

• Full time- W2
• 6 months contract (May be extended or converted)
• $39/hr

Job Description:
The Quality Assurance Specialist will provide Quality oversight to the CMO with the ability to be on site up to support Quality Reviews and QA Shop Floor manufacturing support. You will manage CMO oversight for change management, deviation management, Annual Product Quality reports, Quality Agreements, Risk Assessments and CMO product release. This position may also be cross trained to cover other QA functions as needed.

• Provides oversight for CMO Batch Production Records. Reviews executed Batch Records, GMP documents and prepare documentation for product release/disposition.
• Assists with Document Control and other QA functions.
• Coordinates and assist in timely review of documentation associated with manufacturing at CMO site.
• Assists with preparation for FDA and other regulatory agency audits and inspections. Provides daily summaries and follows the completion of CAPAs from audit findings.
• Gives guidance to CMO as needed and ensure CMO is compliant with Quality standards.
• Ensures that all audit items are resolved. Supports site for Inspection. Reviews any Quality Events, CAPAs from internal and external audits to ensure that actions necessary to provide adequate confidence that the cGMP requirements are completed on time.
• Escalates critical quality problems to Senior Management in a timely manner.

 
Qualifications and Education Requirements:

• BS in Life Sciences or equivalent with 5+ years related experience within a pharmaceutical or Biotechnology Company.
• Hands-on QA Site or ExM Operations / QA Systems experience including supporting Validations within pharmaceutical or Biotechnology Company. Must be fluent in English language.
• Additional experience in an area allied with cGMP Quality, Quality Systems, Biopharma Production Processes, 21CFR 210-211, ICH guidelines, FDA Guidance for Industry for Investigating OOS Results, Deviations, CAPAs, Validation, Stability Studies, QC laboratory operations and manufacturing operations, auditing is preferred.
• Ability to Coordinate Quality oversight and working with other site groups.
• Ability to review Quality documents and ensuring compliance to GMP. Documents to include batch records, logs, and others.
• Ability to be an effective communicator to Management, and line staff.
• Ability to work with other manufacturing teams to implement business objectives.
• Must be very detail oriented and be able to quickly detect errors within documentation

 
Important information: This position is recruited for by a remote Kelly office, not your local Kelly branch.  Applicants must be legally permitted to work in the United States. Please apply online to be considered for the position.
 
As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. That's why we're proud to offer a complete array of voluntary benefits to members of the Kelly talent community.
 
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As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.

Why Kelly® Science & Clinical?

Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the world's most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals—it's the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.

About Kelly

Work changes everything. And at Kelly, we're obsessed with where it can take you. To us, it's about more than simply accepting your next job opportunity. It's the fuel that powers every next step of your life. It's the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life—just ask the 300,000 people we employ each year.

Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly's Human Resource Knowledge Center. Kelly complies with the requirements of California's state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.

 Apply on company website