Quality Auditor (Consultant)

Position Summary

Performs daily audits throughout the facility by reviewing manufacturing and packaging paperwork and areas for internal standard and cGMP-related compliance.

Responsiblities

• Performs the daily tasks as defined by departmental procedures and batch record instructions.
• Performs daily audits of Operations areas and facilities. Ensures that the general housekeeping in the production areas are well maintained in accordance with cGMPs.
• Assists Operations in situations requiring deviation/document resolution.
• Physically labels exception product/components as necessary.
• Assist Document Control with document administration functions as needed.
• Responsible for logging in reserve and laboratory samples for delivery to Laboratory Operations.
• Prepares samples and documents for shipment to contract laboratories and/or MPLS Laboratory.

Qualifications

• Education: High School Diploma or equivalent.
• Experience Years & Type: Minimum of 1-2 years of experience in either the pharmaceutical or medical device industry. Minimum of 1 year experience in manufacturing and/or packaging. Auditing experience and knowledge of Quality Systems a plus.
• Certifications/Licenses: ASQ Certification required.