Quality Sr. Scientist
Quality Sr. Scientist
Org Marketing Statement
All over the world, Pfizer colleagues are working together to positively impact health for everyone, everywhere. Each position at Pfizer touches and contributes to the success of our business and our world. That’s why, as one of the global leaders in the biopharmaceutical industry, Pfizer is committed to seeking out inspired new talent who share our core values and mission of making the world a healthier place.
Position is primarily focused on assay transfer, qualification and/or validation of Quality Control (in-process, characterization, stability, and release testing), with additional responsibilities for document generation and/or authorization, study design, troubleshooting, assessment and implementation of new technologies, continuous improvement, testing support and project management. Cross-functional training and responsibilities within the Quality Organization may be required.
Position will focus primarily on the Microbiology/Biology/Biochemistry area (assays include bioburden, endotoxin, sterility, slot blot, ELISA and microbial identification).
•Provides Quality Review/Oversight of site GMP documentation related to the operation of a vaccine manufacturing facility to ensure compliance with global regulatory agencies and Pfizer quality standards.
•Performs testing including, but not limited to clinical and/or commercial product, raw materials and validation samples.
•Displays strong investigative or technological orientation with independence for design of projects/studies.
•Organizes and provides written and/or oral presentations of work with minimal input.
•Analyzes and interprets results, makes decisions regarding the accuracy, completeness and compliance.
•Responsible for final authorization/approval/release of documentation/equipment/processes.
•Assessing existing situations and suggesting improvements in the Quality systems to increase compliance throughout the facility.
•Plans and leads projects to ensure their timely completion.
•Provide guidance/coaching to junior colleagues.
MINIMUM: 5 to 8 years of manufacturing, quality or engineering experience in the biotech or pharmaceutical industry.
MINIMUM: BS/BA Degree in Science/related field or other appropriate education/experience in biotech or pharmaceutical industry.
University Degree in the field of Engineering, Microbiology, Chemistry, Biotechnology, Biochemistry or Pharmacy or other appropriate education and experience in biotech or pharmaceutical industry is preferred.
TECHNICAL SKILLS REQUIREMENTS:
Technical QC / Microbiological/ Biochemical experience required.
Knowledge of assay transfer, qualification, validation required.
Knowledge of electronic laboratory data management systems such as LIMS/ELNs is preferred.
PHYSICAL POSITION REQUIREMENTS:
Job may be physically demanding, including lifting, standing/sitting for extended periods while performing testing/working at computer terminals/laboratory benches or during environmental monitoring. Gowning into the classified manufacturing environment is required.
Off-shift and weekend work may be required based on business needs.
Occassional travel may be required.
Equal Employment Opportunity
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.
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.
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