Job Description
SUMMARY
Join a growing and trusted pharmaceutical organization dedicated to advancing quality in sterile drug production. As a QA Manufacturing Specialist, you’ll provide direct quality oversight of production operations, ensuring alignment with cGMP guidelines as defined under Section 503B. This role supports compliance in compounding, filling, inspecting, and packaging processes by monitoring critical procedures and documentation. Ideal for detail-driven individuals eager to contribute to regulatory excellence and patient safety.
RESPONSIBILITIES
- Monitor daily production floor activities including compounding, aseptic filling, visual inspection, and packaging to uphold quality standards
- Ensure cleaning protocols are thoroughly followed and documented in manufacturing areas
- Approve product labels and ensure compliance prior to use
- Conduct verification of line clearance, material status, aseptic techniques, and documentation during filling operations
- Ensure personnel follow proper gowning procedures across all production zones
- Identify and document quality events such as deviations, initiate CAPAs, and manage change controls
- Represent QA interests during audits and inspections as needed
- Assist with root cause investigations to drive continuous improvement
- Maintain detailed and accurate batch records, logs, and compliance documentation
- Adhere to company policies and support additional duties as needed
QUALIFICATIONS
- Minimum 3 years of experience in quality assurance within aseptic drug manufacturing, preferably in a 503B outsourcing facility
- High school diploma required; BS in a scientific discipline preferred
- Solid understanding of cGMP, Good Documentation Practices, and pharmaceutical quality systems
- Knowledge of manufacturing operations, automation, and cleanroom practices
- Proficient in Microsoft Office (Word, Excel, PowerPoint); ability to learn new systems as required
- Effective communication skills with ability to work independently and under time-sensitive conditions
- Adaptable to rotating shifts, weekend schedules, and holiday coverage if required
- Physical ability to lift up to 25 pounds and wear required cleanroom attire, including scrubs, gloves, and safety footwear
- Comfortable working in cleanroom environments and with hazardous substances as necessary
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