Associate, GoodLabPract-GLP Training and Compliance, Vaccines

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 activities involved in developing and maintaining quality programs, processes and procedures that ensure compliance with established standards and agency guidelines. Your contribution in quality risk management will help us in commitments tracking, interpreting policies, manage site complaints and work directly with operating entities to provide process analyses oversight.

Thanks to you, we will be prepared for all upcoming audits and inspections. You will be relied on to ensure that the quality assurance programs and policies are maintained and modified regularly. You will make sure that there are uniform standards worldwide and best practice sharing, which will help in fostering the achievement of company's mission globally.

As an associate, your focus on the job will contribute in achieving project tasks and goals. Through your domain knowledge and commitment, you will create a collaborative teaming environment for your colleagues.

It is your hard work and commitment that will make Pfizer ready to achieve new milestones and help patients across the globe.

How You Will Achieve It

• Perform gap analysis to Identify and track gaps/compliance risk regarding quality, compliance and inspection readiness. Assist in development and implementation of preventative action.
• Develop good working practices/guidelines to work as tools to assist staff in the use of quality system SOPs.
• Consult with managers in various groups to coordinate and implement decisions made regarding compliance practices.
• Assist Director of Compliance in VRD in providing compliance direction to all colleagues in GLP/GCLP/GMP issues/matters.
• Assist Director of Compliance in VRD in development and maintenance of appropriate processes for on-boarding and off-boarding for all VRD. Ensure compliance with established processes and proper documentation.
• Consult with managers in various groups to develop appropriate curriculum. Coordinate curriculum management and proactively identify roles within VRD that are impacted by changes to ensure colleagues and contractors are assigned the appropriate training including new hire training, and ensure training compliance.
• Support inspection readiness by ensuring Quality System documentation is inspection ready.
• All other job duties as assigned

• Bachelor Degree in a Science
• Ability to multi-task and prioritize assignments
• Strong communication (written and verbal)
• Computer and systems skills: industry enterprise systems, MS Office applications and a solid understanding and use of relational databases and knowledge of Sharepoint
• Highly skilled in precision checking and verifying data and information with low error rate. Sharp eye for details while maintaining work overview.

Nice-to-Have

• 2+ years proven compliance experience
• Fundamental knowledge of and experience with GLP/GCLP/GMP
• Experience in electronic data systems (e.g. P2L, GDMS, GNOSIS, Pedagogue)
• Some working knowledge of setting up and monitoring/QA of routine GMP processes

PHYSICAL/MENTAL REQUIREMENTS

• Work primarily performed at individual’s desk, computer workshop, or may require walking around to meet with end users or archive documentation.

OTHER JOB DETAILS

• Eligible for Relocation Package
• Eligible for Employee Referral Bonus

#LI-PFE

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.