Senior Scientist Quality Control
Senior Scientist Quality Control
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$ 96300 - 160500
1 Vacancy
Job Description
Use Your Power for Purpose
Every day our unwavering commitment to quality ensures the delivery of safe and effective products to patients. Our flexible innovative and customeroriented culture is rooted in science and riskbased compliance. Whether you are involved in development maintenance compliance or analysis through research programs your contribution directly impacts patients.
What You Will Achieve
Performs or oversees internal or external testing laboratory performance of routine and nonroutine testing and general QC laboratory work for the inprocess support release and/or stability of Pfizer clinical development and/or commercial products in a GMP testing environment.
Principal Responsibilities
Applying the principles of cGMPs on a daily basis
Analyzing and compiling data and preparation of reports & presentations
Overseeing (includes approving protocols & reports) the transfer qualification and validation of analytical methods
Serve as SME for test methods and programs
Troubleshooting laboratory or system anomalies
Lead laboratory & OOS investigations
Representing Quality Control on cross functional project teams
Approving drug product bulk drug substance or intermediates data packets for release or stability timepoint disposition.
Authoring and reviewing technical reports stability summaries SOPs and test methods or other documents to support development manufacturing quality operations and regulatory submissions
Authoring deviations CAPAs and Change Controls
Contributes to optimization of Quality Processes
Have comprehensive understanding of a global quality perspective.
This position primarily interacts with analysts/associates/scientists within Pfizer and/or CMO/CTL quality organizations.
Here Is What You Need (Minimum Requirements)
BA/BS with at least 4 years of experience or MBA/MS with at least 2 years of experience or PhD/JD with any years of experience or associates degree with at least 8 years of experience or high School Diploma (or Equivalent) with at least 10 years of relevant experience
Substantial experience in pharmaceutical manufacturing and quality control
Familiarity with Current Good Manufacturing Practices (cGMP) and handling compliance issues arising from cGMP deviations or product defects
Knowledge of regulations related to vendor management programs and other industry quality systems
Strong critical thinking skills and a proactive approach
Ability to collaborate effectively manage relationships and communicate well both in writing and verbally
Advanced computer skills in MS Office applications and a good understanding of enterprise systems such as PDM Quality Tracking System Trackwise and Documentum platforms
Bonus Points If You Have (Preferred Requirements)
Experience in Quality Systems in pharmaceutical medical device or combination product industry
Knowledge or exposure to data science
Strong leadership and team management skills
Ability to work under pressure and meet tight deadlines
Ability to influence and negotiate with stakeholders
Experience in conducting internal audits and supporting regulatory inspections
NONSTANDARD WORK SCHEDULE TRAVEL OR ENVIRONMENT REQUIREMENTS
Position may require occasional overtime nonstandard working hours weekend and/or holiday support
Work Location Assignment:On Premise
OTHER JOB DETAILS
Last Date to Apply for Job: April 24 2025
Referral Bonus Eligibility: YES
Eligible for Relocation Package: NO
Relocation assistance may be available based on business needs and/or eligibility.
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 providers 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 EVerify employer. This position requires permanent work authorization in the United States.
Required Experience:
Senior IC
Employment Type
Full-Time
