QA Specialist, Lakewood, New Jersey

Renaissance LLC

All 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.


QA Specialist

US-NJ-Lakewood

Job ID: 2024-2746
Type: Regular Full-Time
# of Openings: 1
Category: Quality
Lakewood, NJ

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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