QC Scientist II

Pfizer Inc.

Andover, MA

Job posting number: #7135304 (Ref:pf-4880811)

Posted: March 21, 2023

Application Deadline: Open Until Filled

Job Description

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 Senior Associate scientist, your significant experience of applying knowledge of principles, concepts, and practices of the discipline will make you a critical member of the team. Your skill and knowledge will help in making decisions that require choosing among limited options. Your being proactive in team discussions will help in creating an environment of collaboration.

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

How You Will Achieve It

  • Contribute to the completion of complex projects, manage own time to meet agreed targets and develop plans for work activities on own projects within a team.
  • Analyze and interpret results, makes decisions regarding the accuracy, completeness and compliance.
  • Responsible for detailing requirements for Laboratory Information Management System builds, building, testing and managing its Master Data changes.
  • Serve on cross functional teams to represent Quality Control and facilitate communications and activities/projects between Quality Control and site departments and/or Network.
  • Assist Lab leadership in determining scheduling priorities and workload distribution to ensure customer needs are met.
  • Perform tasks associated with maintaining current Good Manufacturing Practices compliant Quality Control and Stability laboratories.
  • Able to create, review, and approve compliant test method transfer and validation protocols and reports and equipment qualification/computer validation records.
  • Train junior colleagues and develop training plans and oversee training activities for groups.
  • Responsible for contributing to and/or handle laboratory investigations for events and Out of Stock results.
  • Perform testing including, but not limited to clinical and/or commercial product, raw materials and validation samples.
  • Perform laboratory support functions and maintain work area in a neat and orderly manner.
  • Write Standard Operating Procedures, technical reports, project plans and other documents independently.

Qualifications

Must-Have

  • Bachelor's Degree
  • 3+ years' experience
  • Experience within the biopharmaceutical industry, including knowledge and experience relevant to biopharmaceutical unity operations and/or laboratory operations
  • Demonstrated experience in manufacturing, quality or engineering experience in the biotech or pharmaceutical industry
  • Understanding of aseptic laboratory techniques and quality systems
  • Ability to establish relationships within business lines
  • Excellent effective written and verbal communication and interpersonal skills

Nice-to-Have

  • Experience in Quality Operations
  • Laboratory experience, including Cell Culture, Bioassay, Aseptic Technique, and ELISA

  

PHYSICAL/MENTAL REQUIREMENTS

Normal lifting, sitting, standing, and walking requirements to facilitate testing in a laboratory environment.


NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

Position is first shift Monday through Friday. Some off hour (night/weekend/holiday) support may be required to support staff and operations.

Relocation support available
Work Location Assignment: On Premise

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.

Quality Assurance and Control

#LI-PFE


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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