Manufacturing Medical Quality Analyst

Quality Analyst I requires:

• An equivalent combination of education and experience
• Ability to demonstrate flexibility and adaptability
• Ability to prioritize within a changing business environment
• Microsoft Office (Word, Excel, Outlook)
• Ability to work both independently and within a team environment
• Be an advocate for a safe work environment and be responsible for my safety and the safety of others.
• Knowledge of 21CFR Part 820, cGMPs, and ISO 9001 standards ·
• Knowledge of Quality Information Systems (Trackwise, OTIS, Windchill, SAP, Lab Investigations)

Quality Analyst I duties:

• Completes batch record review at the final stage of the manufacturing process with minimal assistance and approves their final release once it has been determined that all compliance and procedural requirements have been met.
• Identify batch record issues and open non-conformances where required.
• Perform records coordinator activities in support of quality record retention on-site and off-site according to quality system procedures.
• Perform other work-related duties as assigned.
• Coordinate with manufacturing associates for the completion or correction of DHR errors.
• Collaborate with the QC Lab and Microbiology teams May interact with regulators
• Lead and/or participate in assigned projects.
• Possesses strong conflict resolution, change management, communication (written and verbal), organizational management, business ethics, and analytical reasoning skills and demonstrates the ability to work in a diverse cross-functional environment