Lab Process Control Associate
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
Clinical Immunology & High-throughput Operations (CIHO) in Pfizer Vaccine Research & Development (VRD) develops, qualifies, and validates clinical immunogenicity assays and uses them to generate high quality clinical assay data supporting the clinical development of Pfizer’s life-saving vaccines.
The Lab Process Control Associate (P01) will report directly to CIHO’s Laboratory Process Control Lead and play a major role in ensuring operational excellence in CIHO’s compliant testing laboratories. The primary responsibility for this position is to assist CIHO’s Lab Process Control Lead to achieve success in aligning laboratory compliance across CIHO, which includes improving the lab process control document cycle times. The position will help the Laboratory Process Control Lead manage several Lab Process Control workflows including but is not limited to (i) Standard Operating Procedures (SOP) undergoing periodic review (authoring, review and approval); (ii) Laboratory Deviation Reports (LDR), Planned Deviation Notes (PDN), and Change Control Requests (CCR) from initiation through approval, required deliverables and any post approval commitments. Other routine duties will include (i) verification of documents associated with laboratory equipment qualification reports; (ii) standardization of common verbiage used in these CIHO documents; (iii) providing assistance in conducting LDR investigations.
How You Will Achieve It
Support operational excellence within CIHO, as follows:
Manage weekly status check for quality events including, but not limited to, meeting and improving cycle times for Laboratory Deviation Reports (LDR), Planned Deviation Notes (PDN), and Change Control Requests (CCR) and associated commitments.
Manage weekly status check for compliance with SOP renewal.
Manage job roles and assigned users across functional groups and ensure proper alignment.
Routinely monitor colleague training records assuring 100% training compliance.
Assist in establishing and implementing harmonized laboratory processes that impact teams.
Perform interviews, collect investigation evidence, and write up preliminary LDR as needed.
Perform preliminary document review (SOP, equipment qualification) using the established tools (eg, checklist).
Satisfactorily complete all required laboratory, cGxP and safety training, in conformance with departmental requirements.
Where applicable, perform job responsibilities in compliance with cGxP and all other regulatory agency requirements.
Qualifications
Must-Have
Bachelor’s degree in a relevant field (eg, science, business administration). with 0-2 years of laboratory experience.
Excellent organizational, communication and technical writing skills; previous experience in performing laboratory investigation is a plus
Knowledgeable with Microsoft applications including Word, Excel and Power Point
Detail-oriented with a commitment to maintaining high-quality standards
Nice-to-Have
Experience of writing and managing deviations
Understanding of cGxP compliance and documentation practices
PHYSICAL/MENTAL REQUIREMENTS
Work is primarily performed at an office desk using a computer. Periodic laboratory inspections take place in the various CIHO laboratory workspaces and requires use of PPE (e.g. lab coat, eye protection)
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
This position may require occasional weekend and evening work to meet critical business timelines.
Other Job Details:
Last Date to Apply for Job: August 29th, 2024
Work Location Assignment: On Premise
On Premise colleagues work in a Pfizer site because it’s needed to get their job done. They may have flexibility to work remotely from time to time, but they are primarily on-site.
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.
