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Job Details


Pfizer: One of the World's Premier Biopharmaceutical Companies

QC Technical Writer

Pharmaceuticals

All

Yearly

Full Time

No

Andover, Massachusetts, United States

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

You will be a member of Pfizer’s dedicated and highly effective quality assurance and control team. You will be responsible for analyzing chemical, biological or microbiological products to support our quality programs. Your contribution to environmental testing, utility monitoring, analytical testing, microbial identification and sterility testing will help Pfizer provide safe drugs to patients.

Your understanding of Quality Control instruments will help us meet their accuracy specifications against established standards. You will also be relied on for setting requirements for the transfer of methodology from R&D.

As a Technical Writer, your depth of knowledge of instrument lifecycle activities, will make you an active team member who influences at the project team level. You will be exposed to a wide variety of opportunities of cutting edge instrumentation and bring them into routine use across different microbiology and analytical environments. You will be using your scientific judgment to adapt standard methods and techniques by applying prior work experience and consulting others. Your ability to plan will help in preparing short-term work activities on projects. Your creativity in developing novel processes and new ideas will be used frequently. You will undertake mentoring activities to guide your team members.

It is your knowledge and skills that will help in making Pfizer ready to achieve new milestones and help patients across the globe.

How You Will Achieve It
  • Create new or revise existing procedures in support of QC instrument lifecycle milestones.
  • Drive new instrument validation projects from a QC perspective
  • Review and approve instrument validation protocols, instrument periodic reviews, data integrity and electronic record assessments.
  • Drive instrument decommissioning projects from a QC perspective.
  • Collaborate with IMEx process technicians across QC to determine instrument health.
  • Maintain QC Instrument Heat Map and provide regular updates on instrument performance/lifespan to QC management,
  • Participate and/or lead Data Integrity (DI) projects.
  • Contribute to Continuous Improvement (CI) projects for QC.
  • Schedule third party instrument maintenance activities.
Qualifications

Must-Have
  • Bachelor's Degree
  • 6+ years' experience
  • Extensive knowledge and practical application of instrument validation.
  • Strong understanding of global regulations and guidance's.
  • Ability to manage multiple projects and timelines concurrently.
  • Ability to receive feedback and takes accountability for actions and personal development
  • Excellent effective written and verbal communication and interpersonal skills
  • Basic computer skills, such as data entry, with a high level of attention to detail, are also required
Nice-to-Have
  • Master's degree and 4+ years of relevant experience
  • Experience leading continuous improvement projects
  • Experience defending laboratory practices in regulatory audit.
  • Experience with EAMS, and/or LIMS.
  • Experience with the Change Control Process.

Other Job Details:

  • Last Date to Apply: March 24 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