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... more details
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. Apply Today! #P2
Job Abstracts is an independent Job Search Engine. Job Abstracts is not an agent or representative and is not endorsed, sponsored or affiliated with any employer. Job Abstracts uses proprietary technology to keep the availability and accuracy of its job listings and their details. All trademarks, service marks, logos, domain names, and job descriptions are the property of their respective holder. Job Abstracts does not have its members apply for a job on the jobabstracts.com website. Additionally, Job Abstracts may provide a list of third-party job listings that may not be affiliated with any employer. Please make sure you understand and agree to the website's Terms & Conditions and Privacy Policies you are applying on as they may differ from ours and are not in our control.
We would like to take a second to Welcome You to Job Abstracts, the nation’s largest Pure Job Board. With over 3.1 million job listings from 15,000+ Companies & Organizations, we help job searchers find careers that match their interests. As an anonymous user, you have probably discovered how easy our system is to use. However, you have just scratched the surface of what we can offer.
We encourage you to Register so you can use our most powerful features: searching with multiple terms, setting up multiple locations, establishing favorite companies, and accessing your search history. If you find a job you like, you can apply directly for it, and then, keep notes on it. We will also keep a lookout for jobs that match your search terms and email you when we find something you may like.
You can register for free and the system is free to use. If you like our system so far, click on Register and unlock the power required by serious job searchers.
Any time you conduct a search, the system shows you job matches, ranked by their Relevance Score (RS).
The score is calculated by a proprietary algorithm that uses Intelligent Machine Learning.
The Relevance Score tells you how well the job opportunity matches your search term or terms.
When not logged in, the system is limited to one search term. Scores for single term matches are usually lower.
When you register, log in, and set up multiple terms prioritized by importance, the jobs found for you will receive a much higher Relevance Score.
