Sr. Quality Specialist (Quality Systems)

Pfizer • North Creek, WA

2d • Onsite

About The Position

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

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 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

Nice To Haves

• 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

Responsibilities

• 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

Benefits

• 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
• 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
• health benefits to include medical, prescription drug, dental and vision coverage

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees