Role and Responsibilities
This position is responsible for working cross functionally to support Quality Assurance & Quality Control tasks, with focus on visual inspection of drug products. The Quality Technician will support Belmar Pharma Solutions in carrying out the mission of the company. This position reports to the Quality Manager.
Responsibilities include:
- Primary responsibility to perform visual inspection of parenteral pharmaceutical products in accordance with regulatory guidelines
- Create & review all labels (in-process and finished goods) and Batch Production Records for accuracy and adherence to Good Documentation Practices (GDPs)
- Incoming materials receipt: inspect, document, unpack, label, shelve, and organize materials
- Obtain samples of raw, in-process, and finished goods materials and send to third party labs for testing. Results to be entered into applicable spreadsheets.
- Review Logs of Use and Maintenance (LUMs) for accuracy and GDP
- Finished drug product batch release checks
- Perform Quality checks on in-process product and facility controls as needed
- Sterilization: Prepare, receive, and organize product for sterilization
- Environmental Monitoring (EM): Collect routing EM samples. Enter, report and trend sample data.
- Identify nonconformances and escalate to leadership
- Attend all required meetings and provide clear, professional verbal and email communications.
- Special projects as assigned by Management
- Other duties as assigned
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