Quality Specialist Validation and Systems
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Job Location:
North Creek, WA - USA
Monthly Salary:
$ 82700 - 133900
Posted on:
Yesterday
Vacancies:
1 Vacancy
Job Summary
Use Your Power for Purpose
Every day Pfizers unwavering commitment to quality ensures the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is both flexible and innovative always putting the patient first. Whether you are involved in development maintenance compliance or research analysis your contribution directly impacts patients.
What You Will Achieve
You will be a member of Pfizers dedicated and highly effective quality assurance team. A Specialist in Quality Validation and Systems is responsible for managing the day-to-day activities of multiple quality programs or processes such as change management document management deviations CAPAs etc. The position is responsible for assisting staff with completion of day-to-day assignments / tasks; ensuring compliance with procedures and implementing program improvements to align with current industry best practices. The Quality Validation and Systems Specialist collaborates with Facilities Engineering QC and other Quality expertsto ensure the quality of products and compliancewith internal standards international regulatory expectations and industry best Quality Validation and Systems Specialist provides quality oversight of facility/utility equipment and method validation documents to support clinical and commercial manufacturing.
You will be relied on to manage operational activities that support the goals of the quality organization and site.
It is your problem-solving ability and teamwork that will make Pfizer ready to achieve new milestones and help patients across the globe.
How You Will Achieve It
Provide assessment for all relevant change controls to determine if there is potential regulatory impact
Provide QA support for the successful completion of cross-functional projects.
Participate as an SME in audits and inspections as needed.
Represent Quality Validation and Systems on cross-functional teams or teams with external parties.
Make collaborative (and some independent) decisions within the areas of expertise with support from management on more complex issues
Support or serve as site Quality for all validation areas
Review/collaborate and/or approve SOPs validation plans protocols and/or reports as required.
Perform change control assessment and approval to assure proper impact assessment and sufficient testing to develop and maintain a validated state
Support review and approval of deviations/incident handling to assess impact on validation as needed.
Support review and approval of CAPA plans and actions so ensure procedures are followed and that validation impacts are addressed
Provide data integrity support to site and partner with corporate data integrity group
Support audits and inspections. (Area SME or other roles)
Other duties as assigned
Qualifications
Must-Have
Applicant must have a Bachelors Degree in Science or Relevant field with at least 8 years of experience; OR a Masters with 4 years of experience; OR a high school diploma (or equivalent) and 10 years of relevant experience
Working knowledge of current industry practices and standards
Advanced expertise with Office 365 especially Word SharePoint Teams and PowerPoint
Experience with applicable software (e.g. Learning Management System electronic Quality Management System data analytics etc.)
Excellent written and oral communication skills
Demonstrated problem-solving skills and techniques commensurate with job level
Ability to manage routine and non-routine workload with little-to-no routine oversight
Expertise in Validation Processes
Expertise in Change Control processes and compliance expectations
Expertise in deviation/CAPA management process
Detail oriented
Bonus Points If You Have (Preferred Requirements)
GMP operational experience in Quality Operations Quality manufacturing or technical services
Prior Data Integrity experience
Ability to work under pressure and meet tight deadlines
Ability to influence and negotiate with stakeholders
NON-STANDARD WORK SCHEDULE TRAVEL OR ENVIRONMENT REQUIREMENTS
This role is on site day shift Monday Friday. Some exceptions may be required to support manufacturing
Some travel may be required but expected to be minimal.
Work Location Assignment:On Premise
OTHER JOB DETAILS
Last Date to Apply for Job: February 26th 2026
Eligible for Relocation Package: NO
The annual base salary for this position ranges from $82700.00 to $133900.00. In addition this position is eligible for participation in Pfizers Global Performance Plan with a bonus target of 10.0% of the base salary. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of lifes moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution paid vacation holiday and personal days paid caregiver/parental and medical leave and health benefits to include medical prescription drug dental and vision coverage. Learn more at Pfizer Candidate Site U.S. Benefits (). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa FL or any location outside of the United States.Relocation assistance may be available based on business needs and/or eligibility.
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 providers 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. This position requires permanent work authorization in the United States.
Pfizer endeavors to make to all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process and/or interviewing please email. This is to be used solely for accommodation requests with respect to the accessibility of our website online application process and/or interviewing. Requests for any other reason will not be returned.
Required Experience:
IC
Key Skills
- Quality Assurance
- FDA Regulations
- Data Collection
- Food Safety Experience
- ISO 9001
- Mobile Devices
- Root cause Analysis
- Quality Systems
- OSHA
- Food Processing
- Quality Management
- cGMP
About Company
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