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Job Details


Pfizer: One of the World's Premier Biopharmaceutical Companies

Quality Operations Associate (4838822_McPherson)

Pharmaceuticals

All

Yearly

No

McPherson, Kansas, United States

Why Patients Need You

Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is flexible, innovative, and customer oriented. Whether you are involved in development, maintenance, compliance or analysis through research programs, your contribution will directly impact patients.

What You Will Achieve

You will be a member of Pfizer’s dedicated and highly effective quality assurance team. You will evaluate and review Pfizer’s clinical and commercial batches of drugs. You will make sure that product and process documents match the specifications based on established sampling and statistical process control procedures. Your expertise will help in identifying deviations from established standards, in the manufacturing and packaging of products. In the relevant cases you will approve investigations and change control activities to ensure compliance with configuration management policies.

As an associate, your focus on the job will contribute in achieving project tasks and goals. Through your domain knowledge and commitment, you will create a collaborative teaming environment for your colleagues.

It is your hard work and commitment that will make Pfizer ready to achieve new milestones and help patients across the globe.

How You Will Achieve It

Quality Operations Associate (QOA) provides Quality Assurance (QA) technical assistance to the Quality Operational Professionals (QA/QOP) and Operations Professionals (Operations) providing on line support to the manufacturing operation in the detection of process drift and the prevention of deviations. The QOA role is responsible for assessing real time quality impact in support of deviation management. Entry level Manufacturing Quality Assurance role that entails accelerated experience and learning to develop and apply academic subject matter expertise within a dynamic pharmaceutical manufacturing environment, providing opportunities for growth and development. Interactions include Operations, Quality Assurance, Quality Control, Process Engineering, Technical Services, and Compliance.

  • Responsible for online collaboration with Manufacturing and QOP teams providing support and detection of manufacturing process drift.
  • Provide real time support for investigations, applying standardized investigation principles and tools to ensure non-conformance investigations are accurate, defendable and follow DMAIC principles.
  • Cooperative role to learn Quality principles and pharmaceutical GMP concepts by partnering with senior Quality Assurance professionals. Participate in Peer Reviews.
  • Develop competency with quality risk management principles.
  • Actively engage in deviation Triage and communicate investigation requirements and needs.
  • Assist or complete data analysis using Pfizer systems and common software to create investigation effectiveness and status metrics.
  • Lead Operations colleagues through prevention and investigational analysis procedures and processes.

Qualifications

Must-Have
  • Bachelor’s degree in Engineering, Business or Science, with 0-3 years of relevant work experience.
  • Able work in a team environment or independently with minimal guidance.
  • Demonstrated desire to understand how things work and get to true root cause.
  • Strong sense of ownership, Collaborative/Active Listener
  • Understanding of Microsoft Office programs, including Word, Excel, Outlook, MS Project or equivalent.

Nice-to-Have
  • Bachelor’s degree in Chemistry, Biochemistry, Microbiology, or other science related discipline.

PHYSICAL/MENTAL REQUIREMENTS

  • Office position with significant time in the production environment.
  • May be required to aseptically gown.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

  • Must be able to work rotating 12-hour shifts (6am – 6pm) and weekends
  • Position may require some weekend and off shift presence as business needs dictate.
  • Successful candidate may be required to complete various levels of gowning certification in order to enter and support manufacturing areas.

Other Job Details

  • Last date to apply: April 12, 2022
  • Eligible for relocation assistance: YES
  • Eligible for employee referral bonus: YES

Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.

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.

Quality Assurance and Control

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