Stability Data Reviewer (1st shift)

Why Patients Need You

Our breakthroughs would not make it to the hands of patients without our pharmaceutical stability laboratory. We rely on a team of dedicated and agile members, who understand the importance and impact of their role in Pfizer’s mission. Patients need colleagues like you who take pride in their work and always look to improve outcomes. You will help to ensure that patients and physicians have the quality medicines they need, when they need them.

What You Will Achieve

You will provide review of laboratory data generated to support product shelf-life. You will be responsible for ensuring adherence to procedures and proper reporting of data.. You will possess strong knowledge of laboratory equipment/techniques, SOPs (Standard Operating Procedures), GMP (Good Manufacturing Practices), standard work and focus on continuous improvement as well as strong organizational, communication, and people skills.

As part of the Scientific and Laboratory Services Stability team, you are part of the team to ensure that product on market is supported by data throughout the shelf-life. You will also participate in laboratory investigations to determine root cause and help implement appropriate CAPAs. You will also be able to improve processes and procedures through change controls for SOPs, testing notes, and other controlled documents. Your business awareness and willingness to expand your skills will elevate the quality of team deliverables. You may be needed to train others and reinforce behaviors that will help us achieve our goal of providing the best healthcare to our patients.

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

How You Will Achieve It

• Manage own time, professional development and be accountable for own results.

• Prioritize own workflow and request support from others if needed to team goals are met.

• Learn activities and tasks associated with own role, and contribute to conversations {e.g., brainstorming and innovation).

• Consistently communicates work status / critical issues to supervisor in a timely manner.

• Follow procedures at all times, adopting current Good Manufacturing Practices {part of GxP} practices.

• Interact and communicate with laboratory analysts, supervisors and other departmental staff

• Use Functional/Technical skills to perform review and approval of chemistry data and results in accordance with procedure, regulatory guidelines (FDA, MHRA, TGA, ICH, and DEA).

• Act Decisively on the acceptability of test data (Empower chromatography and other analytical laboratory data) based on procedures and technical knowledge.

Qualifications

Must-Have

• Applicant must have High School Diploma (or Equivalent) with  6 plus years of relevant experience; OR an Associate's degree with four years of experience; OR a Bachelor's degree with 0-2 years of experience.  

• Experience in QC or R&D laboratory.

• Functional/Technical Knowledge of the discipline - (HPLC, GC, AA, UV-Vis, etc).

• Effective written and oral communication.

• Computer skills, such as Microsoft Applications.

Nice-to-Have

• Experience / Knowledge of LIMS, Empower, PDOCS, gQTS, eQMS.

• Experience with peer review/ data review of laboratory data.

Physical/Mental Requirements

This individual will be required to sit at a desk and work on a computer for extended periods of time.  This individual will also be expected to perform some analytical laboratory activities.  This role also requires the ability to evaluate complex analytical data for accuracy and acceptability and also requires performing review of mathematical calculations.

Non-Standard Work Schedule, Travel, or Environment Requirements

The typical work schedule is 1st shift, Monday-Friday.  Overtime should not be used unless there are business critical needs and management pre-approval is obtained. 

This individual will be required to wear a lab coat, closed toe shoes, and safety glasses when entering the laboratory. 

  
Work Location Assignment: On Premise

Last Date to Apply to Job: February 3, 2023

Relocation assistance may be available based on business needs and/or eligibility.

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.

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