Quality Specialist - Validation and Systems

Pfizer • North Creek, WA

2d • $82,700 - $133,900 • Onsite

About The Position

Use Your Power for Purpose Every day, Pfizer’s 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 Pfizer’s 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 experts to ensure the quality of products and compliance with internal standards, international regulatory expectations, and industry best practices. The 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

Requirements

• Applicant must have a Bachelor's Degree in Science or Relevant field with at least 8 years of experience; OR a Master's 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

Nice To Haves

• 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

Responsibilities

• 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

Benefits

• We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life’s 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level