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Pfizer

Makes cancer drugs, vaccines and other medicines

Quality Assurance Specialist 3

Validation, Compliance & Quality SystemsPosted on Nov 9
Full-timeAndover, MA, USA

About the Job

Requirements

  • High school diploma or equivalent with 8 or more years of experience, an associate’s degree with 6 or more years of experience, or a bachelor’s degree with 2 or more years of experience.
  • Solid understanding of current Good Manufacturing Practices and relevant GxP regulations and standards.
  • Experience in a GMP manufacturing role or a GMP Quality Assurance role.
  • Working knowledge of Microsoft Excel and Word.
  • Candidates must be authorized to be employed in the United States by any employer and have permanent work authorization in the United States.

Responsibilities

  • Provide guidance and lead or co-lead projects for digital solutions.
  • Provide routine updates to the team and management on project milestones.
  • Independently support complex investigations in cross-functional work areas, applying quality assurance judgment to ensure product quality.
  • Review and approve electronic records, protocols, and reports; author, review, and approve standard operating procedures as appropriate.
  • Independently provide quality review and oversight of site documentation to ensure compliance with global regulatory agencies and Pfizer quality standards.
  • Collaborate with coworkers, customers, and management within PGS, and external sites as necessary, to gather input and background knowledge for assignments.
  • Anticipate issues and promptly provide recommendations for a path forward to management.
  • Review and approve change controls for appropriateness, completeness, and alignment with quality, validation, and regulatory expectations.
  • Exercise judgment in resolving complex quality issues.
  • Plan and execute work independently, consulting with a supervisor as needed and recommending solutions.
  • Apply technical and quality concepts, applicable FDA or other regulatory-body guidelines, and relevant standard operating procedures.
  • Lead and drive continuous improvement activities.
  • Apply sound technical judgment proactively and independently to resolve quality issues.
  • Drive effective management of quality issues and corrective action plans (CAPAs), making decisions that may involve complex quality and technical issues.

Desired Qualifications

  • Experience with quality-administered systems.
  • Experience with regulatory compliance and documentation.
  • Experience using common artificial intelligence tools, including generative technologies such as ChatGPT or Microsoft Copilot, to support problem solving and productivity, with curiosity about improving outcomes and understanding responsible artificial intelligence practices, including risk management and ethical use.

About the Company

Pfizer

Makes cancer drugs, vaccines and other medicines

Pfizer discovers, makes, and sells prescription medicines and vaccines for patients, doctors, and governments worldwide, with large businesses in vaccines, cancer, heart disease, and rare diseases. In 2020, its COVID-19 shot, developed with German partner BioNTech, became the first COVID-19 vaccine authorized in the United States. Its scientists find drug candidates and run clinical trials to prove they are safe and effective, and Pfizer then manufactures approved products in its own plants, earning most of its money from patented drugs before cheaper generic copies arrive. Pfizer was founded in 1849 as a chemicals business in Brooklyn and is based in New York City.

Company size
10,001+
Company stage
IPO
Headquarters
New York City, New York
Founded
1849

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