Senior Specialist QO - Vaccine

ROLE SUMMARY

The successful candidate will operate as a Senior Quality Operations Cleaning Validation Professional. In this role, they will provide oversight of the execution of the cleaning validation program, ensuring that contemporary compliance standards and conformance to site procedures are maintained.  The ideal candidate will possess skills and experience in cleaning validation.

ROLE RESPONSIBILITIES

• 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
• 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

QUALIFICATIONS

• A BA/BS degree or higher in organic, analytical, physical or biochemistry or another relevant scientific discipline with a minimum of 3 years of experience.
• This position requires an excellent 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.

  
PHYSICAL/MENTAL REQUIREMENTS

• 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: December 21, 2021
• Eligible for Relocation Package
• Eligible for Employee Referral Bonus

Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment.  As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.

Sunshine Act

Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations.  These laws and regulations require Pfizer to provide government agencies with information such as a health care provider’s name, address and the type of payments or other value received, generally for public disclosure.  Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act.  Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government.  If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.

EEO & Employment Eligibility

Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.  Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA.  Pfizer is an E-Verify employer.

Quality Assurance and Control

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