Pfizer IMEx and Human Error Reduction Manager in Kalamazoo, Michigan
This position will have two primary areas of focus: IMEx implementation into Quality Operations and building a robust Human Error Reduction Program in the Laboratories.
QC Ecosystem Full Scale Deployment requires "Champions" to enable implementation of IMEx holistically throughout the labs
Provide direct help with CI Loop and TPM modules to ensure successful implementation and continuous improvement including Belt Project support
After QC implementation is complete will aid in other IMEx roll outs within the Quality Organization in Kalamazoo Human Error Reduction Program:
Greater than 1800 Deviations (QARs/ERs/LIRs/RAACs) per year in the Lab are due to Human Error
Initially provides capability to address high volume Human Error deviations reactively by building the program and then transitions to proactive elements such as situational awareness and other deviation prevention tools
Ensures alignment with PGS Strategy of Deviation Reduction across the network
Supports all QC IMEx implementations throughout the Kalamazoo Laboratories
Provides direct help with CI Loop and TPM modules to ensure successful implementation and continuous improvement including Belt Project support
After QC implementation is complete, will aid in other IMEx roll outs within the Quality Organization in Kalamazoo
Human Error Reduction:
Develop and Drive implementation of human error reduction initiatives in the QC Laboratories
Initially provides capability to address high volume Human Error deviations reactively by building the program
Transitions to proactive elements such as situational awareness and other deviation prevention tools
Ensure consistent approach to human error reduction across lab organization
Serves as a Human error reduction subject matter expert representing the labs in addition to teaching and mentoring others in key PHP Investigative Principles
The successful candidate will effectively champion belt projects (green or black belt) for the labs in an effort to significantly reduce deviations and non value added activities in the labs
The successful candidate will regularly attend the Site Zero Defect Steering Team meeting to represent the labs and share Zero Defect initiative improvements on a quarterly basis
The successful candidate will be a change agent who is dedicated to driving positive change through their work.
The successful candidate will support our Zero Defects culture through advocating the use of Method 1 and PHP methodologies in day to day activities.
The incumbent will coach/facilitate project teams, assist in Deviation Initiative strategy definition, solve problems, and implement solutions to improve operational performance.
This role includes the responsibility of providing strategic proposals, progress updates and presentations to all levels of the site organization, including Center functions as applicable
BS, MS, or PhD in Chemistry, Biochemistry, Microbiology, Engineering, Pharmacy or related science
Minimum of 5 years of experience in a cGMP environment with a strong working knowledge of a variety of quality systems and processes
The candidate must have demonstrated proficiency in organizational and project management skills, strong problem solving and continuous improvement abilities, and must be able to balance multiple priorities
The candidate must be trained in and demonstrated successful usage of Method 1 and Pfizer Human Performance tools
The candidate must be a certified Green or Black belt
The candidate should have experience in at least several of the following: GMP, Regulatory (worldwide), deviation investigations, investigation techniques (Ex. Method 1, Human Error Reduction, Six Sigma, 5 Whys, etc...), operational excellence, lot release, product and process validation, laboratory testing, or quality assurance.
Communication: Excellent written and verbal communication skills with the ability to share vision, direction, and data with colleagues across all levels and in a wide range of different work groups including senior leadership and regulatory agencies
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.
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Additional Offer Details:
Last Date to Apply for Job: October 19th
This job is Pfizer/Exempt/US/ Grade: 10
A career at Pfizer offers opportunity, ownership and impact.
All over the world, Pfizer colleagues work together to positively impact health for everyone, everywhere. Our colleagues have the opportunity to grow and develop a career that offers both individual and company success; be part of an ownership culture that values diversity and where all colleagues are energized and engaged; and the ability to impact the health and lives of millions of people. Pfizer, a global leader in the bio-pharmaceutical industry, is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.