Associate, Data Integrity
Pfizer Inc.
Pearl River, NY
Job posting number: #7281377 (Ref:pf-4920045)
Posted: September 18, 2024
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
As a member of our Quality, Informatics and Data Operations (QIDO) team, you will assist with data integrity (DI) initiatives and provide quality guidance and oversight to Vaccines Research and Development colleagues that aligns with CFR and EMA guidelines for bioanalytical laboratories and Pfizer quality standards. You will primarily be responsible for the testing and validation associated with implementation of DI solutions and assisting with Quality Assurance oversight activities of the Vaccine R&D laboratories. Efforts should be made to seek and embrace continuous improvement opportunities within VRD with an emphasis on quality and data integrity.
How You Will Achieve It
- Partner with Informatics operations analysts, architects, developers/engineering leads and equipment asset owners to ensure VRD information system landscape meets short-term and long-term needs.
- Ensure compliant processes exist, and follow those processes, for data collection on instruments and that validated processes exist for non-standard systems.
- Ensure compliance related projects are properly established and deadlines communicated.
- Review and approve SOPs, Test Methods, validation documentation and reports for compliance with CFR, EMA and VRD SOP requirements as a DI or Quality reviewer.
- Review and participate in Data Integrity and compliance assessments of laboratory instruments and software.
- Identify performance gaps in information systems and investigate new areas for improvements.
- Escalate Data Integrity concerns or potential Quality Events to VRD management in a timely manner.
- Participate and lead where appropriate in the validation of computer systems, instrument qualifications, or hardware processes.
- Write departmental SOPs; maintain technical paperwork and migrate such data to archive repository.
- Provide support across various Quality management processes, including the VRD change control programs.
- Maintain strong connections and communications with line SMEs, leading efforts to map the sequential movement of information and data that feed into digital products to ensure data integrity.
- Lead efforts across Bio Process R&D group lines to identify gaps and define solution requirements for Digital Products by understanding end user requirements.
- Maintain and continuously develop knowledge of global GxP regulations and guidelines as they apply to VRD. This knowledge should be used to make quality decisions in all job responsibilities.
- Completes all cGMP/cGLP/cGCP/GCLP, corporate and safety training in conformance with Departmental requirements.
QUALIFICATIONS
Must Have
- BS in a relevant scientific field and 0-2 years of cGMP or GLP/GCLP experience OR
- Strong communication and collaboration skills
- Laboratory or manufacturing experience in a GxP regulated industry preferred
- Experience with information systems preferred
- Experience with Microsoft Office and data base applications
PHYSICAL/MENTAL REQUIREMENTS
- Ability to perform work while standing/sitting.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
- This position may require weekend or evening work to meet critical business timelines.
- This position may require travel to scientific meetings, between Pfizer sites, to external laboratories, and other business-related travel.
Other Job Details:
- Last Date to Apply for Job: 02 OCTOBER 2024
- Eligible for Employee Referral Bonus
Work Location Assignment: Flexible
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 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. This position requires permanent work authorization in the United States.
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.
