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.