QO Specialist A&I

Employer
Pfizer
Location
Kalamazoo, Michigan
Posted
Oct 08, 2021
Ref
4822114
Required Education
Bachelors Degree
Position Type
Full time

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

  • Responsible for acting as a site representative for external inspections, as well as a system owner for site internal audit program elements. 
  • Interfaces heavily with site personnel, as well as colleagues in Pfizer Center One and regulatory authorities, in order to ensure successful execution of site inspections by both customers and regulators. 
  • Focus on products manufactured in Kalamazoo, having responsibility for the support of those products, globally.
  • Acts as the primary resource for ensuring inspection readiness, at the site. 
  • Engage in providing input for the development of site strategies, in order to ensure compliance with global regulatory expectations.
  • Support the successful completion of the site's mock audit process
  • Support the corrective Action/Preventative Action (CAPA) Coordinator. Will act 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 as needed.

Qualifications

Must-Have

  • BS in Chemistry, Biochemistry, Microbiology, or related science
  • Two years of relevant experience, particularly in quality or compliance roles
  • Demonstrated ability in developing scientific reasoning and problem solving with minimal coaching, as well as excellent written and oral communication skills. 
  • Experience with internal audit programs and/or regulatory inspections.

Nice-to-Have

  • 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.
  • Have excellent negotiation skills, and will be able to frequently resolve issues with a focus on regulatory compliance. 
  • Have demonstrated skill in developing solutions, and will do so with a flexible approach to the development of options.

  

 

PHYSICAL/MENTAL REQUIREMENTS

During support of audits walking of the site and standing will be required.


 

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

Hours to support the audit of the site will be extended during site inspections. In addition during site internal audits aseptic gowning will be required.

Relocation support available

Other Job Details:

  • Eligible for Relocation Package: Yes
  • Eligible for Employee Referral Bonus: Yes.

#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.

Quality Assurance and Control

#LI-PFE