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QO Specialist - Supplier Management

Employer
Pfizer
Location
Rochester, Michigan
Start date
Sep 23, 2022

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Job Details

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

The Supplier Management Professional will be responsible for ensuring that site standards, policies and procedures are aligned with global Pfizer Quality Standards and regulatory agency’s guidance’s and are operating in a state of compliance.

Procure and maintain suppliers and materials used by Rochester by qualification, performing supplier assessment reports and qualification evaluations, monitoring compliance/quality performance of suppliers/materials.

Facilitate compliance by coordinating the introduction, development, selection and delivery of appropriate training and education programs.

How You Will Achieve It

ROLE RESPONSIBILITIES

The essential functions of the position include, but not limited to:

  • Support departments in the onboarding of vendors/materials.
  • Collaborate with various sites to performs re-evaluation of Vendors.
  • Maintains the Vendor’s Qualification Evaluation.
  • Communicates change notifications, quality and compliance issues to respective User Sites.
  • Verifies Vendor details and assigns qualification status in Supplier Management System.
  • Assures Quality Agreement is initiated.
  • Assures GMP audit is performed or on audit plan, as applicable.
  • Communicates critical issues to Senior Management.
  • Tracks CAPAs from any investigation or audit.
  • Leads collaboration with impacted sites to develop CAPA for activities that may impact Vendor qualification status.
  • Identifies, creates, and assigns status to Supply Channels.
  • Performs Risk Assessments to assess impact.
  • Communicates with Vendors during investigations.
  • Point of contact for supplier and materials inquiries.
  • Support regulatory agency/corporate inspections as Supplier Management subject matter expert.
  • Role will require after hour and weekend support from time to time.
  • Attend and present supplier metrics at the Site Quality Review Team Meeting
  • Assist in the review of area documentation and perform trend analysis on data, controls and standards.

Must haveApplicant must have High School Diploma (or Equivalent) with six years of relevant experience; OR an Associate's degree with four years of experience; OR a Bachelor's degree with 0-2 years of experience.

The candidate must have demonstrated proficiency in organizational skills, balance multiple priorities, aptitude for technical learning, and problem solving. The candidate must have experience in at least several of the following:

  • Experience with suppliers/contractors.
  • Strong verbal and written communication including presentation skills.
  • Has strong technical experience and Advanced computer skills with quality systems (change control, deviations, SAP, documentation management, audits, inspections, etc.).
  • Demonstrated ability to manage multiple projects and complex suppliers, with strong negotiation skills.
  • Able to work and contribute effectively in cross-functional team, culture differences, diversity.
  • Show strong negotiations and effective communication skills with internal and external business partners.
  • Knowledgeable in both domestic and international GMP regulations and industry guidance documents (e.g. ICH, PDA, ISO, PIC/S, and ISPE)
  • Familiar with quality auditing
  • Familiar with QC Laboratories, Manufacturing and Packaging Operation
  • Knowledgeable with continuous improvements and best industry practices
  • Experience with conduction gap assessment and system and process risk assessments
  • Basic understanding of aseptic manufacturing

Nice to have

  • Two years related cGMP experience in Quality Operations.
  • Prior experience in a GMP quality team environment strongly preferred.
  • Knowledge of drug/device combination product requirements is highly desirable.

Communication: Excellent written and verbal communication skills with the ability to share requirements, direction, and data with colleagues across all levels and in a wide range of different work groups including senior leadership and regulatory agencies. Ability to act decisively in real time and communicate/defend decisions and observations made during internal site system audits and assessments.

Reasoning Ability: Strong analytical, critical thinking and problem solving abilities.

Technical: Comprehensive understanding of cGMP guidelines outlined in CFR. Knowledge and demonstrated ability to apply Pfizer Quality Standards to ensure local practices and procedures reflect these requirements. Independently writes SOPs, technical reports, validation/qualification documents, project plans, etc. Basic understanding of aseptic manufacturing highly desirable.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

Must not be allergic to penicillin.

Minimal travel for training/seminars.


Work Location Assignment:On Premise

Last Date to Apply for Job: October 7, 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.

Quality Assurance and Control

#LI-PFE

Company

Join world-class scientists and leaders who are dedicated to bringing therapies that will significantly improve patients' lives.

As one of the world's premier innovative biopharmaceutical companies, we're driven to discover the cure --driven to significantly improve the lives of everyone...everywhere. If you're similarly driven, you'll find there's no better place to begin --and continue --your career than at Pfizer.

Science is the foundation of our company.  This is why it's no surprise that the most driven scientists in the world choose to carry out their life's passion at Pfizer.  We arm them with the resources, technology, and facilities they need to solve some of the world’s most complex health challenges. This combination empowers our scientists with expertise in vaccines, small-molecule medicines, biotherapeutics amongst many others, to collaborate on breakthrough science, including the world's first mRNA-Based Covid19 vaccine.  Our colleagues advance science and technologies into the therapies that matter most.

Join us and you'll partner with colleagues of diverse backgrounds and abilities who contribute to all aspects of what we do. Great things happen when people come together with one shared goal. If you're driven to discover the cure- ensure it has the latest technology to make it a reality or help improve the lives of others- join those who are similarly driven at Pfizer. The future of medicine is happening here.

Visit www.pfizer.com and connect with us.

 

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Find Us
Website
Phone
(212) 733-2323
Location
235 East 42nd Street
New York, NY 10017
United States
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