Manufacturing Quality Assurance Specialist
2 days ago
We are seeking a highly skilled Manufacturing Medical Quality Analyst to join our team at Global Channel Management.
Key Responsibilities- Conduct batch record reviews at the final stage of the manufacturing process with minimal assistance and approve final release once compliance and procedural requirements are met.
- Identify batch record issues and open non-conformances as required.
- Perform records coordinator activities in support of quality record retention on-site and off-site according to quality system procedures.
- Collaborate with the QC Lab and Microbiology teams, and lead or participate in assigned projects.
- 2 years of experience at a medical or manufacturing facility; or a minimum of a high school diploma or GED with 3-5 years experience in a medical or manufacturing facility.
- Ability to demonstrate flexibility and adaptability, prioritize within a changing business environment, and work both independently and within a team environment.
- Knowledge of 21CFR Part 820, cGMPs, and ISO 9001 standards.
- Microsoft Office (Word, Excel, Outlook) skills.
- Knowledge of Quality Information Systems (Trackwise, OTIS, Windchill, SAP, Lab Investigations).
As a Manufacturing Medical Quality Analyst at Global Channel Management, you will have the opportunity to work in a diverse cross-functional environment, possess strong conflict resolution, change management, communication, organizational management, business ethics, and analytical reasoning skills.
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