Sr. Associate, Investigator

Why Patients Need You

Pfizer's purpose is to deliver breakthroughs that change patients' lives. Research and Development is at the heart of fulfilling Pfizer's purpose as we work to translate advanced science and technologies into the therapies and vaccines that matter most. Whether you are in the discovery sciences, ensuring drug safety and efficacy or supporting clinical trials, you will apply cutting edge design and process development capabilities to accelerate and bring the best in class medicines to patients around the world.

The Andover Liquid Dosage Manufacturing (AN-LDM) is located on the Pfizer Andover, MA campus and is responsible for the cGMP manufacture of phase I/II clinical drug product supporting the Pfizer Biotherapeutics portfolio.

What You Will Achieve

Andover Liquid Dosage Manufacturing (AN-LDM) Investigator is responsible for writing investigations and implement Corrective Action/Preventive Action (CAPAs) in the Pfizer system for AN-LDM facility.

The candidate will also interact with ANLDM Ops; ANLDM Engineering; ARD-MST, ARD-QC and PSQA for investigation purposes.

How You Will Achieve It

• Initiate and document incidents in the Pfizer system according to current procedures.
  
• Interact directly with manufacturing and/or ARD MST, ARD QC to investigate all (event report (ER) and quality assurance report (QAR)) to identify root cause.
  
• Propose corrective and preventive measures that respond to the underlying cause of the investigation
  
• Interact with PSQA to ensure ER and QAR are conducted appropriately.
  
• Ensure that each investigation is completed on a timely manner and follows the process defined in internal procedures and the type M1 methodology for problem solving.
  
• Promptly escalate any unforeseen situation or irregularity found in the investigation process.
  
• Follow up with CAPA ensuring efficacy.
  
• Review of standard operating procedures and working with ANLDM Ops for incorporating Pfizer Human Performance (PHP) principles if deemed necessary.
  
• Support with SOPs revision as required.
  

Qualifications

Must-Have

• HS diploma +9 years of experience in related industry
  
• Associate degree with 3 to 5 years of experience in a GMP investigation/technical writing position.
  
• BS degree with 3+ years of experience in a GMP investigation/technical writing position.
  
• Excellent written and verbal communication skills, including technical writing skills
  
• Strong attention to detail, along with excellent communication, collaboration, and organizational skills.
  
• Proficient with time management.
  

Nice-to-Have

• BS in a technical or science field
  
• Knowledge of cGMP and an ability to handle multiple tasks
  
• Proficient in Microsoft Office (Word, Excel)
  
• Prior experience writing cGMP manufacturing investigations
  
• Working knowledge of Trackwise.
  
• 5+ years in regulated pharmaceutical industry
  

PHYSICAL/MENTAL REQUIREMENTS

• Collaborative skills and effective partnering skills in complex working environments
  
• Ability to work in a dynamic multi-discipline organizational model
  
• Ability to work independently and multi-task in a fast, priority environment
  
• Ability to understand technical documentation relevant to tech transfer
  
• Ability to react to unforeseen circumstances and mitigate accordingly.
  

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

• Minimal travel required
  
• Ability to gown to enter non-aseptic and aseptic areas of the LDM.
  

Other Job Details:

• Last Date to Apply for Job: December 22nd, 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

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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.

Research and Development