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Pfizer Global Clinical Supply and Vendor Quality Assurance Associate in St. Louis, Missouri

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, your contribution will directly impact patients.

What You Will Achieve

You will be a member of Pfizer's dedicated and highly effective vendor quality operations team. You will be responsible for activities involved in developing and maintaining quality programs, processes and procedures that ensure compliance with established standards and agency guidelines. Your contribution in quality risk management will help us in commitments tracking, interpreting policies, manage site complaints and work directly with operating entities to provide process analyses oversight. Thanks to you, we will be prepared for all upcoming audits and inspections. You will be relied on to ensure that the quality assurance programs and policies are maintained and modified regularly. You will make sure that there are uniform standards worldwide and best practice sharing, which will help in fostering the achievement of the company's mission globally.

As a Senior Associate, your knowledge and skills will contribute towards the goals and objectives of the team. Your focus and ability to meet team targets will help in completing critical deliverables. Your innovative use of communication tools and techniques will facilitate in explaining difficult issues and establishing consensus between teams.

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

How You Will Achieve It

  • Vendor Point of Contact for vendors, including qualification and oversight.

  • Maintain central mailbox for vendor quality operations.

  • Maintain systems with accurate data for vendors.

  • Contribute to the completion of complex projects, manage own time to meet agreed targets and develop plans for work activities on own projects within a team.

  • Evaluate applicable corrective and preventive action responses to the audit findings for adequacy and timeliness.

  • Ensure Quality Assurance Auditing policies and procedures are kept up to date and aligned with Pfizer Quality standards and Regulatory requirements.

  • Prepare and participate in Manufacturing and Supplier Quality Assessment Audits (RQA) and BOHs Inspections to the site, ensuring successful results, and timely implementation/closure of action plans.

  • Contribute to quality assurance management team initiatives and objectives.

  • Assist in the process of gathering, interpreting and applying statistical methods to various Quality related processes and communicate those through reports, memos, files and presentations.

  • Implement and adhere to {Current} Good Manufacturing Practices {part of GxP} regulations and company policies.

Qualifications

Must-Have

  • Applicant must have High School Diploma (or Equivalent) with eight years of relevant experience; OR an Associate's degree with six years of experience; OR a Bachelor's degree with at least three years of experience; OR a Master's degree with more than one year of experience.

  • 5+ years' GMP experience.

  • Strong knowledge and understanding of Quality System functions, manufacturing / packaging processes, validations, engineering drawings and basic statistical processes.

  • Ability to understand and apply mathematical concepts especially as it relates to statistics and probability.

  • Good technical writing skills, and communication as well as presentation skills.

  • Working knowledge of Microsoft 365, Statistical Software including Spotfire and SMS.

Nice-to-Have

  • Auditor certification (ASQ)

Work Location Assignment:Remote (US)

Last Date to Apply: November 21, 2022

Relocation assistance may be available based on business needs and/or eligibility.

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.

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