Inactive
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Pfizer

Makes cancer drugs, vaccines and other medicines

QA Specialist 3

Regulatory & Quality (Life Sciences)Posted on Oct 21
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 of Arts/Bachelor of Science with 2 or more years of experience.
  • Solid understanding of current Good Manufacturing Practices and relevant GxP regulations and standards.
  • Experience in a Good Manufacturing Practice manufacturing role or a Good Manufacturing Practice Quality Assurance role.
  • Working knowledge of Microsoft Excel and Word.
  • Ability to work effectively within the employee's own team and interdepartmental teams.

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 and provide quality assurance judgment to ensure product quality as needed.
  • Review and approve electronic records, protocols, and reports; author, review, and approve standard operating procedures as appropriate and when required for support.
  • Independently provide quality review and oversight of site documentation to ensure compliance with global regulatory agencies and Pfizer quality standards.
  • Collaborate with or independently engage a wide range of coworkers, customers, and management within Pfizer Global Supply, and external sites as necessary, to gather input and background knowledge needed to complete assignments.
  • Anticipate issues and provide recommendations for a path forward to appropriate management attention immediately.
  • Review and approve change controls as needed for appropriateness, completeness, and alignment with quality, validation, and regulatory expectations.
  • Exercise judgment in resolving complex quality issues.
  • Plan and execute work independently, consult with a supervisor as needed, and provide a recommended solution.
  • Know and apply technical and quality concepts, applicable guidelines of the FDA or other regulatory bodies, and relevant standard operating procedures.
  • Lead and drive continuous-improvement activities.
  • Proactively and independently apply sound technical judgment to resolve quality issues.
  • Drive effective management of quality issues and Corrective Action Plans (CAPAs), and make decisions that may involve complex quality and technical issues.

Desired Qualifications

  • Experience in 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 enhance productivity; curiosity about how these tools can improve outcomes and understanding of 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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