QA Specialist
Company: Renaissance LLC
Location: Lakewood
Posted on: July 28, 2022
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Job Description:
Renaissance LLCAll qualified applicants will receive
consideration for employment without regard to race, color, sex,
sexual orientation, gender identity, religion, national origin,
disability, veteran status, age, marital status, pregnancy, genetic
information, or other legally protected status.OverviewThe QA
Specialist role is to review manufacturing batch records, testing
results and deviation reports for compliance with cGMP and company
procedures with minimal supervision. To release products, drug
product components and container-closures. To review and write cGMP
procedures under supervision. To report periodic quality
metrics.The ability to read, write and speak English is a
requirement of the job. Responsibilities--- Review manufacturing
batch records, testing results and deviation reports--- Interact
with other departments to address review observations--- Release
drug product, drug product components and container-closures---
Interact with customers on batch record reviews and batch
releases--- Attend department meetings on batch record review and
releases--- Maintain and report quality metrics on batch record
review and releases--- Review and write standard operating
procedures--- Review quality system documents (change controls,
validation, complaints)--- Review master batch records and maintain
records--- Process, investigate and follow-up on product
complaints--- Perform other tasks as requested by
management.QualificationsBachelor's Degree (BA or BS), preferably
in a Natural Science, is required. A minimum of 3 years of relevant
experience in the pharmaceutical industry is
required.PI184261939
Keywords: Renaissance LLC, Lakewood , QA Specialist, Other , Lakewood, New Jersey
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