Pfizer Quality Operations Professional in McPherson, Kansas

Role Summary

This posting is for a position on the Quality Assurance on the Floor team supporting deviations and providing real time quality impact support (including off shift and weekends) in McPherson Drug Product Operations. The colleague will need to effectively work/communicate with key stakeholders and peers to ensure timely completion of non-conformance investigations reports with effective corrective/preventative actions (CAPA).

Role Responsibilities

  • Independently provide Real Time Quality impact assessments and decisions (24/7) on Drug Product issues as needed:

  • Ability to handle complex and detailed situations

  • Accurately assess consequences of decisions

  • Accurately assess potential Regulatory impacts on a Global basis

  • Immediately escalate issues with potential market or stability impact

  • Accurately communicate Supply/Operational needs/perspectives as well as QO perspectives.

  • Participates in QAR Gembas with customers and peers

  • After initial assessment of QARs and ERs, successfully transitions remainder of investigation to others to complete investigation write up as needed

  • Effectively leads/facilitates/participates/completes cross-functional team investigations for FARs and Significant Deviations and when applicable aids in drafting of AQRT summary

  • Utilize tools such as Method 1 and Pfizer Human Performance in the course of the investigations

  • Participate in QRM assessments that gain approval through Site and Area QO Management

  • Participate in Green/Black belt projects, RFT% Improvement projects, CAPA Effectiveness, etc... as appropriate

  • Propose and implement improvements in the Deviation and/or Floor Support operations

  • Independently assess a wide range of Change Control activities to determine potential Quality and Operational GMP impacts

  • SME support during Regulatory/Customer audits including contributions to strategies to successfully respond to auditor concerns

  • Participates in internal GMP audits

  • Effectively communicate complex technical issues to all levels of Management (including outside of Quality)

  • Actively demonstrate Pfizer leader behaviors.

Qualifications

Education: Preferred BS in Chemistry, Biochemistry, Microbiology, Engineering or other science related discipline.

Experience: Minimum 2 -4 years pharmaceutical experience. Preferred experience writing and managing deviations. Quality Assurance experience preferred.

Soft Skills: Strong Leader Behaviors - willing to lead by example and jump right in, Demonstrated desire to understand how things work and get to true root cause, Strong sense of ownership, Collaborative/Active Listener, Effectively manages stressful situations - able to focus on task at hand and focus others regardless of circumstances and stress induced pressure

Other Skills: Independently, with minimal guidance, consistently produces quality work. Must be able to work in a team environment within own team and interdepartmental teams. Must work under short timelines while maintaining quality work. Must have effective written and oral communication skills.

Additional Offer Details:

  • Last Date to Apply for Job: July 13, 2018

  • This job is Pfizer (Exempt) (US/PR) Grade: 14

  • Relocation Assistance being provided

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.