Supplier Quality Assurance - Sr. Associate

Employer
Pfizer
Location
Sanford, North Carolina
Posted
May 16, 2022
Ref
4852954
Required Education
Bachelors Degree
Position Type
Full time
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 position will support the Pfizer Sanford, NC site by performing Quality Assurance activities associated with clinical and/or commercial product. Key responsibilities are managing supplier test method transfer to contract laboratories, performing supplier and material qualification activities associated with new and existing materials and services; periodic review activities associated with existing materials and services; review of supplier change notifications for existing materials and services; and suggesting improvements and conducting continuous improvement activities. In addition, the position will be responsible for ensuring alignment with above site quality requirements.

The successful candidate will be responsible for developing processes and procedures to perform these responsibilities. This will require working collaboratively with cross-functional groups, at the Sanford site and across the Pfizer network.

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
  • Collaborate with contract laboratories to determine verification, qualification and validation requirements for material supplier test method transfers and answer questions
  • Manage material supplier test method transfers to third party contract laboratories for full testing of materials
  • Identify contract laboratories and obtain quotes for methods transfers
  • Review of contract laboratory test method protocols and results
  • Author test method transfer final reports
  • Performs other QA material qualification activities including:
    • Review/Approval of material safety risk questionnaires
    • Author/Review/Approval of production material release specifications
    • LIMS build requests
    • Quality approval of SAP master data
    • Author/review/approve and/or participate in material related risk assessments
  • Performs QA supplier qualification activities including:
    • Supplier assessment and supplier audit reviews
    • Author/Review/Approve supplier qualification reports
    • Supply channel approvals
    • Assess/author supplier and cross-site quality agreements
    • Author/review/approve and/or participate in supplier related risk assessments
  • Performs supplier change notifications including monitoring and quality assessments
  • Support material and supplier related change controls
  • Interfaces with other parts of the organization such as Global Quality Operations groups and Pfizer Research and development groups
  • Authors/Reviews/Approves annual product reviews related to suppliers and materials
  • Contribute to the completion of projects, manage own time to meet agreed targets and develop plans for work activities on own projects within a team
  • Escalate issues to management
  • Suggest improvements and conduct continuous improvement activities
  • Maintain regulatory compliance in accordance with current Good Manufacturing Practices {part of GxP} practices
  • Support external agency inspections and internal audits, as needed
  • Provide Quality Review and oversight of site cGXP documentation related to the operation of a vaccine manufacturing facility/laboratory to ensure compliance with global regulatory agencies and Pfizer quality standards
  • Accurately communicate Supply/Operational needs/perspectives as well as Quality Operations (QO) perspectives
  • Provides support for other QA functions, e.g. quality investigations

QualificationsMust-Have
  • BS/BA Degree in Science/related field
  • 3+ years of QC laboratory, quality or validation experience in the biotech or pharmaceutical industry
  • Knowledge of current Good Manufacturing Practices and the applicable GxP regulations and standards including different pharmacopoeias (i.e. USP/NF, EP, JP)
  • Proactive approach and strong critical thinking skills
  • Must be able to work in a team environment within own team and interdepartmental teams
  • Excellent communication and interpersonal skills
  • Good working knowledge of Microsoft, Excel and Word

Nice-to-Have
  • 1-2 years of QC laboratory, quality or validation experience in the biotech or pharmaceutical industry with a MS Degree in Science/related field
  • Previous experience with Test Method Transfer and qualification/validation activities is preferred.
  • Experience with Drug Substance and Drug Product commercial manufacturing preferred.
  • Willing to lead by example and jump right in, desire to get to root cause, collaborative and active listener
  • Effectively manages stressful situations, able to focus on task at regardless of circumstances and stress induced pressure


PHYSICAL/MENTAL REQUIREMENTS

Ability to stand for 1-2 hours at a time, sit for 2 to 3 hours at a time. Require working in an office setting where sitting and computer usage would be the norm.

OTHER INFORMATION

Last day to apply May 17, 2022

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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