QA Specialist
8 months ago
Employment Information
Overview:
Qualifications:
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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