Environmental Quality Manager

6 days ago


Lawrence, Kansas, United States PLASTIKON HEALTHCARE, LLC Full time

Job Summary:

PLASTIKON HEALTHCARE, LLC is seeking a highly skilled and experienced Microbiology Manager to lead our environmental quality team. The ideal candidate will have a strong background in microbiology and a proven track record of managing day-to-day activities related to environmental quality processes and practices.

Key Responsibilities:

  • Provide technical support and leadership for sterilization processes, method development, and project work.
  • Establish and manage testing schedules for timely release of products and materials in alignment with business goals and priorities.
  • Ensure the pharmaceutical site cleaning and disinfection program is adequate to control the cleanroom environment to applicable company, regulatory, and statutory requirements.
  • Act as the site EQ technical lead for internal and external stakeholders, regulatory inspections, and business requirements.
  • Maintain certification procedures for test methods and testing personnel.
  • Support activities assigned by Quality Leadership to facilitate testing, qualification, system improvements, and compliance.

Requirements:

  • A minimum of 10 years' experience in a pharmaceutical quality control role, operating in an FDA-regulated GMP environment.
  • A minimum of 5 years' supervisory/management experience is required.
  • Flexibility and ability to manage multiple and competing priorities.
  • Ability to multi-task with a strong sense of urgency and meet deadlines.
  • Self-motivated, dependable, well-organized, and able to communicate effectively and efficiently, both orally and in writing.
  • Must hold excellent problem-solving skills.
  • Excellent attention to detail and capable of performing dependable, accurate work.
  • Bachelor's degree from an accredited college or university in microbiology or a related science field.

Language Skills:

Required reading, writing, and speaking fluently in English.

Work Environment:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.


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