Aseptic Quality Coach 12-shifts (B2 1800-0600) in McPherson job in McPherson
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About Pfizer |
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 biopharmaceutical industry, is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.
The purpose of this role is to work with all Operations on site to continuously improve the awareness, understanding and application of aseptic control practices in the execution of production activities/ related activities. Through this awareness and understanding the individual will assist in the achievement or "best in class" standards in aseptic processing operations.
1.Continuously observe, review, and assess aseptic practices on the manufacturing floor, as applicable to each Manufacturing Suite. 2.Provide immediate feedback during routine observation in an effort to develop colleague capabilities. 3.Observe, coach and continuously improve knowledge of microbiological science, microbiological control strategies, microbiological/environmental monitoring program and how each impacts aseptic processing. 4.Provide SME knowledge of aseptic practices within the site cleanrooms. 5.Evaluate aseptic process performance to support efficient and effective process operations. 6.Candidate at should be well versed in the following topics: a.Basic Microbiology b.Clean Room Behavior c.Aseptic Technique 7.Evaluate aseptic processes during validation smoke studies 8.Observe aseptic technique during validation media fill simulations
Bachelor's degree, preferably in science or leadership, or equivalent work experience with competence in aseptic processing, aseptic behaviors and project management. History of positive interaction with regulatory agencies is strongly preferred. Requires the following skillset: *Strong written and verbal communication skills *Tactful, persuasive and assertive human relations skills *Effective leadership skills *Comprehensive knowledge of GMPs, applicable SOPs and production processes, and inspection practices Strong ability to multi task and project manage to an established timeline PHYSICAL/MENTAL REQUIREMENTS: -The capability to aseptically gown -The capability to focus attention on the colleagues behaviours' that in turn leads to higher than normal performance -Ability to hold self and other accountable and to encourage colleagues to take personal responsibility for their performance / actions -Demonstrated ability of strong self-awareness -Knowledge of pharmaceutical manufacturing and regulatory compliance -Willingness to develop others and to share ideas -Demonstrated aptitude to execute Aseptic techniques to a high degree of proficiency. -Expert at providing constructive feedback that leads to positive reinforcement NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS: -Personnel monitoring results must meet acceptable levels. -Stand for up to 8 to 12 hours depending on assigned area. -Vision must be correctable to 20/20. -Must be able to communicate and work well interdepartmentally, as well as, with all plant departments. -Must be able to read and write, as well as, follow written and oral instructions. -Must be capable of performing data entry into calculators and computers. -Must be able to gown aseptically and retain certification. -Must be self-motivated, able to work independently and have a problem solving mindset. -Perform all tasks in a safe manner. -Maintain proper documentation - Training records, batch records, check sheets, log books. -Promote a positive team environment. -Ensure that environmental excursions are kept to an acceptable level.
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.