Scientist I Lab Ops

Why Patients Need You

Job Description:

The Quality Lab Support group is seeking a highly motivated candidate to provide solution formulation support in the GMP (Good Manufacturing Practice) Solution Chemistry laboratory.

This is a Scientist I position in a high pace Laboratory. Majority of the time is spent in the lab preparing reagents for the onsite commercial and clinical quality groups using small laboratory instruments and large equipment such as autoclaves.

The candidate must have excellent organization skills with strong problem-solving skills and experience with technical writing. Cross training with other teams in the group is expected. Must be a team player in a dynamic small group environment.

The successful candidate will also be responsible for providing various summaries and updates in the form of presentations to the group and upper management.

Responsibilities:
  • Individual has knowledge of solution compatibility and serves as a liaison between the scientific community and the media labs.
  • Is involved in all aspects of media/buffer formulation and the use of related laboratory equipment and associated documentation following established SOPs.
  • Understands applications and limitations of equipment and techniques.
  • Follows Standard Operating Procedures (SOP's) and utilizes proper safety precautions when handling chemicals using Safety Data Sheets (SDS's).
  • Writes and revises technical documentation.
  • Strong problem-solving skills will be used to recognize and evaluate existing and potential problems.
  • Experience and judgment will be used to determine appropriate course of action (escalation, documentation, contact end user, etc).
  • As a subject matter expert, the individual will serve as a resource to other lab personnel.
  • Candidate will provide support in investigations, impact assessments, OOTs as well as data reviews.


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.

Your understanding of Quality Control instruments will help us meet their accuracy specifications against established standards.

As a scientist I, 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
  • Train junior colleagues and develop training plans
  • Responsible for contributing to and/or handle laboratory investigations for events and Out of tolerance results.
  • 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
  • LabWare LIMS experience
  • Technical Writing experience


PHYSICAL/MENTAL REQUIREMENTS
  • ability to perform mathematical calculations
  • ability to perform complex data analysis
  • Excellent effective written and verbal communication and interpersonal skills


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

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