Qualification Supervisor Position Description
- The Qualification Supervisor participates in evaluating, developing, planning and implementing qualifications of new equipment and processes. The Qualification Supervisor is responsible for writing, reviewing, and executing protocols and reports regarding the qualification of equipment for the purpose of improvements in current product processes, as well as completing the qualification of new processes from their early development stages through to implementation.
- Create IQ/OQ/PQ protocols and reports. Work within document management system.
- Assist in the execution of IQ, OQ and PQ for production processes and utilities.
- Assist Operations with new processes including sourcing of equipment and services for process installation and qualification.
- Assist with Validation Studies of new and revalidated processes.
- Assists in the preparation and execution of validation and revalidation studies.
- Assist in writing change controls and reporting impacts of changes to products, processes or equipment.
- Assists in ensuring the Qualification Master Plans are current.
- Assist in developing cleaning validation protocols and cleaning validation reports.
- Assist in creating standard operating procedures for new or current equipment as necessary.
- Other duties may be assigned as deemed appropriate by management.
- Four year Bachelor Degree in Engineering, Science or related field.
- 1 to 3 years of validation experience in s GMP/GLP environment.
- Strong analytical, oral communication, and technical writing abilities.
- Demonstrate mechanical & computer aptitude.
- Strong understanding of GMP.
- Ability to fluently work with Microsoft Word, Excel, Minitab and other applicable software systems as necessary.
- Medical, Dental, and Vision Insurance
- 401K Plan
- Life and AD&D Insurance
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.