Specialist QO - Vaccine
The QO Cleaning Validation Specialist works in a fast paced customer-oriented, environment to support a variety of customers across the plant.
· Generating and/or reviewing/approving cleaning validation documentation
· Executing cleaning validation protocols
· Perform surface sampling of production equipment
· Advising on equipment improvements or replacements
· Provides subject matter expertise in the area of cleaning validation to customers, including QC Laboratories, other Pfizer sites, customers, CMC, and QA
· Training production on division procedures related to cleaning
· Development of cleaning verification assays
· In addition to monitoring the overall progress of the program, establishes necessary Kalamazoo cleaning validation guidelines in accordance to both corporate and industry standards
· Further duties can include the review and remediation of cleaning failure investigations and change control
· A BA/BS degree or higher in organic, analytical, physical or biochemistry or another relevant scientific discipline with a minimum of one year of experience in a pharmaceutical environment.
· A fundamental understanding of laboratory instrumentation function and analytical method troubleshooting and a dedication to meeting timelines.
· This position requires a working knowledge of Good Manufacturing Practices (GMPs).
· The successful candidate must possess the ability to work with a sense of urgency and the ability to prioritize tasks.
· Excellent oral and written communications as well as strong technical and analytical problem solving skills are critical.
· Working in a production environment which will include proper gowning for the area
· Lifting items (typically less than 25 lbs.)
· Working with or around chemicals
· Position also requires office work, which includes working at a computer workstation
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
· Position may require colleague to work off-hours, weekends and/or holidays to meet business or customer needs.
· Proper gowning for the production areas, including aseptic gowning, will be required.
Other Job Details:
- Last Date to Apply for Job: August 13, 2021
- Eligible for Relocation Package