Sr. Quality Specialist (Quality Systems)
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Job Location:
North Creek, WA - USA
Monthly Salary:
$ 96300 - 160500
Posted on:
10 hours ago
Vacancies:
1 Vacancy
Job Summary
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 Pfizers 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 bachelors degree with at least 2 years of experience; OR a masters degree with 0 years of experience;
OR an associates degree with 6 years of experience; OR a high school
diploma (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 $96300.00 to $160500.00. In addition this position is eligible for participation in Pfizers 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 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:
Senior 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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