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Renaissance Services · 3 days ago
QA Specialist
Lakewood, NJ
Full-time
Onsite
Mid Level
$72K/yr - $90K/yr
3+ years exp
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Insider Connection @Renaissance Services
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
Ensure quality and timely review of notifications, deviations and CAPAs; both commercial and development
Final closure and delivery of PRs to the client
Creation of, follow up and closure of CAPAs
Ensure extensions for PRs are completed adequately
Work with other departments to ensure quality and timeliness of deviations/notifications
Lead triage and notify clients of new PRs
Attend/host client meetings, prepare detailed agenda, communicate directly with client, manage client requests/follow up on documents
Prepare metrics
Perform other tasks as requested by management
Qualification
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Required
Bachelor’s Degree (BA or BS), preferably in a Natural Science
Minimum of 3 years of relevant experience in the pharmaceutical industry
Company
Renaissance Services
Renaissance is a leading international facilities management and service solutions company, listed in Oman on the Muscat Stock Exchange.
5,001-10,000 employees
Funding
Current Stage
Late StageCompany data provided by crunchbase
