United States Job Openings
Pfizer
Aseptic Compliance Process Specialist
Rochester
FULL TIME
August 28, 2024
What You Will Achieve
How You Will Achieve It
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Provides operational support to the aseptic training organization which includes but is not limited to oversight of aseptic observations, SOP’s, and training curricula.
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Train new colleagues in proper aseptic gowning techniques.
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Observe and coach colleagues in aseptic practices.
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Investigate deviations associated with Environmental Monitoring, Personnel Monitoring, Aseptic Facility, and other associated aseptic deviations. Performs root-cause analysis and identifies appropriate, effective corrective actions. Implements corrective actions in conjunction with the appropriate enabling groups, ie engineering, maintenance, quality, validation, environmental health and safety.
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Identifies and helps implements cost savings ideas, specifically area efficiency improvements.
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Sustain standard work practices with the aseptic facility.
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Support cost saving initiatives, regulatory changes, and network requests associated with aseptic practices/facilities as needed.
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Applicant must have a High School Diploma (or Equivalent) and 6 years of relevant experience OR an associates degree with 4 years of experience OR a bachelors degree with 0+years of experience.
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Strong written and verbal communication skills
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Tactful, persuasive and assertive human relations skills
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Effective leadership skills
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Comprehensive knowledge of c GMPs, applicable SOPs and production processes, and inspection practices
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Ability to multi-task and manage projects to an established timeline.
Nice-to-Have
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Experience leading colleagues that perform aseptic activities.
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Proficient using Quality Tracking System (QTS).
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Knowledge of manufacturing and regulatory compliance.
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Knowledge of computer systems and Microsoft Office Suite.
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Able to work individually and in a matrix team structure.
PHYSICAL/MENTAL REQUIREMENTS
- The capability to aseptically gown. Vision must be correctable 20/20.
- Must not have a Penicillin allergy.
- Achieve acceptable personnel monitoring results.
- Long periods of standing may be involved.
Work Location Assignment: On Premise
- Last Date to Apply for Job: September 9, 2024
- Referral Bonus Eligibility: YES
- Eligible for Relocation Package: YES
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