Pfizer Manager, Auditor in New York City, New York
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 team. You will conduct audits of third parties/vendors, in particular in the analytical and safety third party laboratories. Your expertise will help in identifying deviations from established standard in the conduct of pre clinical and clinical trials.
As an Auditor (Manager), your advanced knowledge of the principles and concepts in the discipline and comprehensive knowledge of other disciplines will enable you to lead complex projects across Regulatory Quality Assurance.
It is your problem solving ability that will make Pfizer ready to achieve new milestones and help patients across the globe.
How You Will Achieve It
Conducts wide range and GxP (Good Practices Quality Guidelines and Regulations) of third parties/vendor audits, (i.e. Routine or Non-Routine, pre-clinical, toxicology sites, etc.) in accordance with RQA (Regulatory Quality Assurance) risk-based processes
Assesses compliance of vendors processes against ICH (International Conference of Harmonization), applicable government agency regulations/ guidelines, as well as Pfizer policies, procedures and industry standards; applies comprehensive working knowledge of Quality Assurance, regulations and auditing
Conducts RQA audits reports, results to project team personnel and management, and interacts with various teams to ensure corrective actions are taken to bring QA observations to closure as applicable
Develops and delivers awareness sessions with minimal supervision on various GCP (Good Clinical Practice)/GCLP (Good Clinical Laboratory Practices)/GLP (Good Laboratory Practices) topics internally and externally
Acts as a strong technical resource and is called upon to resolve GCP/GCLP/GLP issues based on knowledge of relevant SOPs (Standard Operating Procedures), GCP, GLP, GCLP regulations and guidelines as well as local regulations
Consistently demonstrates expertise in the use of different Pfizer systems
Contributes to RQA by undertaking a variety of roles or assignments to further develop internal processes and people
Routinely suggests new audit techniques/aids in areas of technical expertise; strong ability to operationalize create ideas proposed; frequently engages new ideas or ways of doing things and influences creative thinking
Designs and actively participates in special assignments on various project teams and work streams as determined by RQA management
Actively supports regulatory inspections or corporate audit activities
Ensures rapid communication of QA issues, including potential misconduct or issues of
significant deviation with projects/products to appropriate leaders and colleagues
Provides training and mentorship to less experience members of RQA colleagues
Exemplifies ability to work in a culturally diverse environment
Provides subject matter expertise representing RQA at cross-functional forums and/or projects as endorsed by RQA management
Bachelor's degree or equivalent experience
8 or more years of relevant pharmaceutical experience (i.e. analytical laboratory, safety laboratory, clinical and/or nonclinical research,) including at least 2 years previous clinical/nonclinical Quality Assurance experience conducting a broad range of audits
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Travel Required: Requires approximately 40-60% time for conducting audits (including travel) and attending QA meetings
Other Job Details:
Last Date to Apply for Job: March 8, 2021
Additional Location Information: North America - Any Pfizer Site; Collegeville, PA; Groton, CT; La Jolla, CA; Canada - Remote; United States - Remote
Eligible for Employee Referral Bonus
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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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