A&I QO Specialist
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
This position is responsible for acting as a site representative for the audits and inspections team supporting the internal audit program, supplier audit program, regulatory inspections/customer audits, Inspection Readiness program and CAPA program. The role interfaces heavily with site personnel, as well as colleagues in Pfizer Center One and regulatory authorities, in order to ensure successful execution of site audits/inspections by both customers and regulators. The role exists with a focus on products manufactured in Kalamazoo, having responsibility for the support of those products, globally. This position acts as the primary resource for ensuring inspection readiness, at the site.How You Will Achieve It
Support one or more of the following site programs:
Internal Audit Program: Execute site internal auditing program, including: Develop and execute audit plans, perform regular walkthroughs, review inputs from Quality Auditors, and compose audit reports. Assist with audit management activities in SharePoint and QTS. Develop and report Audits & Inspections-related metrics for the Site Quality Review Team and Device Quality Management Review Team.
Supplier Audit Program: Execute supplier audit program, including: Develop, communicate and execute audit plans. Issue audit report and follow up with supplier to assure an appropriate and effective CAPA plan has been developed by the supplier. When needed, complete supplier impact assessments. Develop and report supplier audit-related metrics for the Site Quality Review Team and Device Quality Management Review Team.
Regulatory Inspections/Customer Audits: Support site external inspection management processes. Work directly with external inspectors, including those from regulatory agencies, and PC1 customer to define inspections plans. Communicate those plans to site colleagues. Organize visitor logistics, such as meals, visitor access, etc. Act as point-of-contact for auditors, and host visiting customer auditors for the duration of their audits.
Inspection Readiness Program: Support the mock audit program on the site by determining logistics, organizing the event for cross site involvement, involving the audits and inspections staff to support the successful completion of the event. Support the development of the Site Inspection Readiness Plan and preparing for the Inspection Readiness meetings. Aid in the completion of Regulatory Observation Network Assessments (RONA) and Regulatory Information Network Assessments (RINA).
CAPA Program: Serve as the corrective Action/Preventative Action (CAPA) Coordinator. Will acts as an administrator for the Commitment Tracking module in QTS, Assist site QTS users with CAPA record creation and management, as needed, Enters new CT Commitment CAPAs into QTS.
Bachelor’s degree in Chemistry, Biochemistry, Microbiology or related science
2+ years of relevant experience in quality or compliance required (Pharmaceutical Industry preferred)
Demonstrated ability in developing scientific reasoning and problem solving with coaching, as well as excellent written and oral communication skills.
Able to engage colleagues globally, and will do so in a manner that recognizes the organizational and cultural differences that may exist between their partners around the world.
Master’s degree in Chemistry, Biochemistry, Microbiology or related science with at least 1 year of experience in quality or compliance required (Pharmaceutical Industry preferred)
Last day to apply: 4/21/2022
Employee Referral Bonus eligible
Relocation support available
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.
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.Quality Assurance and Control#LI-PFE