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20 days old

Specialist, Quality Assurance/ Batch Record

Kelly Services
Somerset, NJ 08873
Specialist, Quality Assurance/ Batch Record


Somerset, NJ 08873


Temporary to Hire


Required Skills:


+ Batch review or batch release experience in final stages with finished products

+ Familiar with documentation related to Master Production Records (MPRs)

+ Must have cGMP experience.

+ Aseptic process working on a manufacturing lined

+ Familiar with TrackWise, JD Edwards (JDE), ERP or similar


Job Description:


+ Perform first Quality review and release of executed batch records.

+ Review and certify component release documentation and released Raw Material documentation for production use.

+ Review QC Chemistry and Microbiology Certificates of Analysis for all applicable products manufactured. Review of specific in-process, and finished product test data.

+ Report of weekly/monthly/quarterly metrics (Right the First time, Error free and Success Rate) to Quality Management. Facilitate and Coordinate with Project teams to enhance, improve and streamline batch records cycle time.

+ Document retrieval from local files and archives, as required for submissions and customer requests. Assist in process audits and internal audits as needed.

+ Report Error Weekly Metrics (Right the First Time) found during review to Management.

+ Works closely with QA functional teams to align and promote awareness on data integrity and good documentation practices.

+ Navigate through various online platforms, including JDE and Track Wise

+ Facilitate and support online platforms implementation including Veeva and BMRAM.

+ Initiate product non-conformance investigations and deviation investigations in Track Wise as necessary.


Education and Experience:


+ BS degree in a science related field (i.e. analytical chemistry, chemistry, biology)

+ 3+ years demonstrated excellence in the pharmaceutical industry.

+ Must have a complete knowledge of cGMP, USP, current Code of Federal Regulations (21 CFR parts 11, 210, 211, 820) and other FDA regulations and guidances.


**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: 2021-08-30 Expires: 2021-09-30

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Specialist, Quality Assurance/ Batch Record

Kelly Services
Somerset, NJ 08873

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