QA Specialist

4 weeks ago

Lakewood New Jersey, United States Renaissance Lakewood LLC Full time
Overview:
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.

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. 

 

Qualifications:
Bachelor’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.

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