QA Specialist

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.

• 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. 

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.