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Sr. Quality Specialist (Quality Systems)

Pfizer

Bothell, WA

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JOB DETAILS
SKILLS
Analysis Skills, Best Practices, Business Development, Business Processes, Change Control, Communication Skills, Continuous Improvement, Corrective and Preventative Action (CAPA) Systems, Cross-Functional, Customer Relations, Data Analysis, Detail Oriented, Document Change Management, Environmental Regulations, Federal Laws and Regulations, GMP (Good Manufacturing Practices), Government, Healthcare Providers, Incentive Programs, Industry Standards, Learning Management System (LMS), Maintain Compliance, Manufacturing, Mentoring, Negotiation Skills, Operational Support, Operations Management, People Management, Performance Reviews, Policy Implementation, Presentation/Verbal Skills, Problem Solving Skills, Process Development, Process Management, Program Evaluation, Quality Assurance, Quality Management, Regulations, Regulatory Requirements, Risk, Staff Training, State Laws and Regulations, Systems Analysis, Team Player, Time Management, Training/Teaching, Willing to Travel, Writing Skills
LOCATION
Bothell, WA
POSTED
30+ days ago
Use Your Power for Purpose


Every day, our unwavering commitment to quality ensures the delivery of safe and effective products to patients. Our flexible, innovative, and customer-oriented culture is rooted in science and risk-based compliance. Whether you are involved in development, maintenance, compliance, or analysis through research programs, your contribution directly impacts patients. It is your problem-solving ability and teamwork that will make Pfizer ready to achieve new milestones and help patients across the globe.


What You Will Achieve


In this role, you will: Be a member of Pfizer's dedicated and highly effective quality assurance team. A Sr. Specialist in Quality 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 training staff in their programs; 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 position must be able to interact with staff at various management levels and make presentations to internal and external customers on specialized and highly technical aspects of the relevant programs. Position is responsible for assessing all Change Controls for potential regulatory impact and must have expert knowledge of change control process. You will be relied on to manage operational activities that support the goals of the quality organization and site.


How You Will Achieve It


+ Manage multiple quality process or program, including

+ leading discussions with mid- to senior staff on status of key activities and risks within the program

+ assisting junior to mid-level staff with performing program assessments and activities

+ own and manage SCRC (Site Change Review Committee) activities

+ developing new business processes

+ developing and providing training for the process or program

+ processing complex records that may involve external parties

+ Support audits and inspections. (Area SME or other roles)

+ Provide assessment for all change control to determine if there is potential regulatory impact

+ Lead the successful completion of cross-functional projects.

+ Represent site as LPO for Quality Systems (Deviation, CAPA, Change Control)

+ Participate as an SME in audits and inspections, as needed.

+ Represent Quality Systems on cross-functional teams or teams with external parties.

+ Lead continuous improvement activities that may involve a team

+ Review staff training assignments

+ Make independent decisions within the areas of expertise, with support from management on more complex issues

+ Mentor and potentially supervise entry-level associates

+ Other duties as assigned


Here Is What You Need (Minimum Requirements)


+ Applicant must have a bachelor's degree with at least 2 years of experience; OR a master's degree with 0+ years of experience;OR an associate's degree with 6 years of experience; OR a high schooldiploma (or equivalent) and 8 years of relevant experience

+ Working knowledge of current industry practices and standards

+ Advanced expertise with Office 365, especially Excel

+ 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 Change Control process and regulatory requirements of change types

+ Expertise in deviation/CAPA management process

+ Excellent verbal and written communication skills, with the ability to share vision, direction, and data with colleagues across all levels and in a wide range of different work groups

+ Detail oriented


Bonus Points If You Have (Preferred Requirements)


+ GMP operational experience in Quality Operations, Quality manufacturing, or technical services

+ Ability to work under pressure and meet tight deadlines

+ Ability to influence and negotiate with stakeholders


PHYSICAL/MENTAL REQUIREMENTS


N/A


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.


OTHER JOB DETAILS


Last Date to Apply for Job: 1/1/26


Work Location Assignment: On Premise


The annual base salary for this position ranges from $96 300,00 to $160 500,00. In addition, this position is eligible for participation in Pfizer's Global Performance Plan with a bonus target of 12,5% of the base salary and eligibility to participate in our share based long term incentive program. 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. Learn more at Pfizer Candidate Site - U.S. Benefits | (uscandidates.mypfizerbenefits.com). 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 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. This position requires permanent work authorization in the United States.


Pfizer endeavors to make www.pfizer.com/careers accessible 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 disabilityrecruitment@pfizer.com. 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.


Quality Assurance and Control

About the Company

P

Pfizer

A career at Pfizer offers opportunity, ownership and impact. All over the world, Pfizer colleagues work together to positively impact health for everyone, everywhere. Our colleagues have the opportunity to grow and develop a career that offers both individual and company success; be part of an ownership culture that values diversity and where all colleagues are energized and engaged; and the ability to impact the health and lives of millions of people. Pfizer, a global leader in the biopharmaceutical industry, is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.
COMPANY SIZE
5,000 to 9,999 employees
INDUSTRY
Biotechnology/Pharmaceuticals
FOUNDED
1849
WEBSITE
http://www.pfizer.com

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