A&I Senior QO Specialist - Auditor

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 commitment tracking, interpreting policies, 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 the company's mission globally.

As a Senior Specialist, your knowledge and skills will contribute towards the goals and objectives of the team. Your focus and ability to meet team targets will help in completing critical deliverables. Your innovative use of communication tools and techniques will facilitate in explaining difficult issues and establishing consensus between teams.

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

This position is for a Site Internal Auditor as part of the Audits and Inspections team. The role will be responsible for acting as a system owner/contributor for site internal audit program elements. The role interfaces heavily with site personnel from all areas across the entire site, in order to ensure successful execution of SIA (Site Internal Audits). The role exists with a focus on products manufactured in Kalamazoo, having responsibility for the support of those products, globally. This position will work with a team of auditors to ensure that the site meets the audit schedule. The role is often engaged in providing input for the development of site strategies, in order to ensure compliance with global regulatory expectations.

How You Will Achieve It

• The main focus of this colleague will be the SIA Program:
  
• Site Internal Audit Program: Execute and lead site internal auditing program to meet regulatory requirements, including:
  
• Develop and execute audit plans
  
• Perform regular area tours
  
• Review internal documents, records and SOP's
  
• Interface with colleagues from all departments across the site
  
• Ensure site processes are in alignment with Regulations
  
• Review inputs from Quality Auditors
  
• Compose audit reports - including writing audit findings
  
• Assist with audit management activities in eQMS and QTS
  
• Develop and report Audits & Inspections-related metrics for the Site Quality Review Team and Device Quality Management Review Team
  
• Contribute to the completion of projects, manage own time to meet agreed targets and develop plans for work activities on own projects within a team.
  
• Demonstrate good planning, organizing, time management and team participation skills.
  
• Clearly communicate progress and issues to peers.
  

Other opportunities to train and learn when time permits:

• Regulatory Inspections/Customer Audits: Support the entire Kalamazoo site for the 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 for the site. 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.
  
• 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.
  
• Support and help coordinate colleagues across the entire Kalamazoo site, other Pfizer sites, above-site Pfizer colleagues, Pfizer customers, Pfizer suppliers and External Inspectors.
  
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• Participate in the site and network-wide teams to provide alignment and support on key items such as Internal Audits, Supplier Audits, Inspection Readiness Program, and the CAPA Program.
  

Qualifications

Must-Have

• Applicant must have eight years of relevant experience; OR an Associate's degree with six years of experience; OR a Bachelor's degree with at least three years of experience; OR a Master's degree with more than one year of experience.
  
• Must be detail oriented with expert knowledge of 21 CFR Part 11, 21 CFR Part 820, ISO 13485 pertaining to CAPA, data analysis and management responsibilities
  
• The successful candidate will have demonstrated ability in developing scientific reasoning and problem solving with minimal coaching, as well as excellent written and oral communication skills. They will be 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. They will also have excellent negotiation skills and will be able to frequently resolve issues with a focus on regulatory compliance. They will have demonstrated skill in developing solutions and will do so with a flexible approach to the development of options.
  
• Understanding Quality Management Systems in a GMP regulated environment.
  
• Experience with internal audit programs and/or regulatory inspections is preferred.
  

Nice-to-Have

• Experience with internal audit programs and/or regulatory inspections is preferred.
  

PHYSICAL/MENTAL REQUIREMENTS

Office environment primarily, with regular entry into production areas.

• Must be able to work independently, with minimal guidance, and consistently produce quality work.
  
• Must be able to work in a team environment within own team and interdepartmental teams.
  
• Must have effective written and oral communication skills.
  
• Must be able to multi-task, meet deadlines, and maintain a high standard of work even with short timelines.
  
• Must have the ability to handle complex and detailed situations.
  

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Relocation support available

Work Location Assignment:On Premise

Last Day To Apply: February 13th, 2024.

The annual base salary for this position ranges from $78,000.00 to $130,000.00. In addition, this position is eligible for participation in Pfizer's Global Performance Plan with a bonus target of 10.0% of the base salary. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life's moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site - U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States.

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.

Quality Assurance and Control

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