Specialist QO - Vaccine

Employer
Pfizer
Location
Kalamazoo, Michigan
Posted
Jul 30, 2021
Ref
4820653
Required Education
Bachelors Degree
Position Type
Full time

ROLE SUMMARY

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

ROLE RESPONSIBILITIES

  • Reviews change control and performs validation impact assessments for new equipment/processes and changes to existing equipment/processes.
  • Represents the unit as a customer interface on equipment/process teams to support all phases of validation.
  • Reviews and approves verification and change control documentation supporting new equipment/processes and changes to existing equipment/processes.
  • Supports validation as an SME during customer and regulatory audits for all areas of responsibility.
  • Participates in execution of unit performance objectives.
  • Supports and facilitates compliance initiatives.
  • Supports the unit where needed to assure due dates and customer needs are met.
  • Performs additional tasks as determined by the department manager to support the unit.

QUALIFICATIONS

  • Bachelor’s degree in a scientific discipline with a minimum of one year of experience in a pharmaceutical environment
  • GMP and/or pharmaceutical validation and change control experience preferred. Excellent written and verbal communication skills, with the ability to interact with senior leadership and regulatory agencies.

  

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

Weekends and/or holidays may be required.

Other Job Details:

  • Last Date to Apply for Job: August 13, 2021
  • Eligible for Relocation Package

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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