Quality Assurance Specialist

Summary

The Quality Assurance Specialist role will provide hands-on support to Visby's manufacturing environment. This position performs the QA review of batch records for final products intermediates sub-assemblies and reagents. The ideal demonstrated ability to address challenges with creative problem-solving techniques.

Essential Duties

• Review executed compounding batch records, and associated documentation for compliance with cGMPs/GDP and consistency.
• Coordinate lot release schedule with Operations and Warehouse management to ensure efficient and on time release of product batches.
• Assisting in the development of Procedures, Batch Records and review checklists for compliance with cGMPs/GDP and consistency
• Must have effective communication and interpersonal skills across all functions within the organization and outside.
• Strong organizational and record keeping skills are required.
• Strong working knowledge of Word, Excel, and PowerPoint is necessary.
• cGMP training of manufacturing operators
• Performs other duties as assigned.

Education and/or Experience

• Minimum: High School diploma or equivalent GED.
• Preferred: Four-year college degree or equivalent Quality experience.

Other Qualifications

• Excellent written and interpersonal communication skills.

Physical Demands

• Comfortable performing repetitive tasks and/or motions.
• Must be able to lift a minimum of 10 lbs.