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Qc Analytical Scientist I

Company

Pfizer

Address , Andover, 01810, Ma
Employment type FULL_TIME
Salary
Expires 2023-06-09
Posted at 1 year ago
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 an Associate scientist, your strong foundation in general scientific practice and in the principles and concepts of the discipline will help us achieve our goals. You will be relied on as a technical contributor to assess the assigned tasks and make decisions that involve direct application of your knowledge.
It is your dedication and focus that will make Pfizer ready to achieve new milestones and help patients across the globe.
How You Will Achieve It
  • Maintain all related data and records in compliance with cGMPs and quality procedures.
  • Perform and review analytical testing of in-process, drug substance, and drug product samples.
  • Participates inn continuous improvement culture within labs. Utilizes continuous improvement tools such as DMAIC.
    • Prepares and record buffers and reagents, etc., and maintain work area in a neat and orderly manner.
    • Perform and review analytical testing of in-process, drug substance, and drug product samples.
    • Identify basic technical issues, atypical or out-of-specifications test results, instrument
    malfunctions and methodology problems and participates in the investigation to resolve and correct.
    • Maintain all related data and records in compliance with cGMPs and quality procedures.
    • Perform laboratory support functions and maintain work area in compliance with cGMP and quality procedures.
    • Participates inn continuous improvement culture within labs. Utilizes continuous improvement tools such as DMAIC.
  • Perform laboratory support functions and maintain work area in compliance with cGMP and quality procedures.
  • Prepares and record buffers and reagents, etc., and maintain work area in a neat and orderly manner.
  • Identify basic technical issues, atypical or out-of-specifications test results, instrument
Qualifications
Must-Have
  • Experience working in cGMP, regulatory environment.
    • B.S. in Biology, Chemistry or related scientific discipline with a minimum of 2 years of related laboratory experience.
    • Lab Experience in basic analytical methods: HPLC, UV, pH
    • Strong oral and written communication skills
    • Knowledge and understanding of cGMP and industry standards
    • Proficiency with computer systems (Microsoft Office applications, LIMS, etc.).
    • Experience working in cGMP, regulatory environment.
  • Proficiency with computer systems (Microsoft Office applications, LIMS, etc.).
  • B.S. in Biology, Chemistry or related scientific discipline with a minimum of 2 years of related laboratory experience.
  • Knowledge and understanding of cGMP and industry standards
  • Lab Experience in basic analytical methods: HPLC, UV, pH
  • Strong oral and written communication skills
Nice-to-Have
  • Experience defending laboratory practices in regulatory audit
  • Experience with and in depth understanding of Analytical testing: Peptide map and Oligosaccharide, iCE, Bioassay, CE

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.

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