McPherson, Kansas, United States
Onsite
Use Your Power for Purpose
Pfizer is driven by an unwavering commitment to delivering safe and effective products to patients. Our science and risk-based compliant quality culture is both flexible and innovative, always putting the patient first. Your contributions will be vital and will have a direct impact on patient care, ensuring we deliver on our promise of quality and safety.
The Senior Quality Associate, QRM is responsible for quality assurance in relation to Quality Risk Management program. The role interfaces heavily with site personnel that are completing activities quality risk management including the site quality risk register. The role is engaged in site processes and projects at varying levels, acting as the quality oversight in the quality risk management processes ensuring compliance with procedure and compliance requirements.
What You Will Achieve
Responsible for SME strategic review and evaluation of quality risk assessments and potential risks that impact the McPherson plant including complex projects/risk assessments
Monitors quality system metrics and executes actions to ensure quality system performance.
Provide support and act as liaison to business units, corporate, and stakeholders for quality risk management process including updates to quality risk register.
Serve as the McPherson site resource for quality risk management, ensuring compliance/procedural requirements are met.
Acts as quality authority for quality risk management.
Identify and act on improvement opportunities for quality risk management processes
Able to support other quality functions.
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 school diploma (or equivalent) and 8 years of relevant experience
Understanding of code of federal regulations around cGMP and medical devices (21 CFR Part 210, 211, 820).
Experience in quality, production and/or production systems in a GMP regulated environment.
Ability to coach peers in quality management systems.
Good verbal, written and interpersonal communication skills.
Proficient computer skills in Microsoft (MS) Word, Excel and PowerPoint required. Experience with electronic quality systems preferred.
Bonus Points If You Have (Preferred Requirements)
Strong relationship management, communication and presentation skills.
Experience with quality risk management including risk register management.
Strong verbal, written and interpersonal communication skills.
Strong understanding of quality risk management principles and applications.
Experience with quality risk management including risk register management.
Experience with using Veeva quality management systems, i.e. eQMS or similar software.
PHYSICAL/MENTAL REQUIREMENTS
Evaluating and reviewing electronic documents
Office environment with some production floor interaction (minimal)
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Be able to support 24/7 manufacturing site
Other Job Details:
Work Location Assignment: On Premise
Last day to apply: June 10
Relocation assistance may be available based on business needs and/or eligibility.

Candidates must be authorized to be employed in the U.S. by any employer.
U.S. work visa sponsorship (such as TN, O-1, H-1B, etc.) is not available for this role now or in the future.

Sunshine Act
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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.
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Quality Assurance and Control
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