Microbiology Quality Assurance Manager

1 week ago

Lawrence, Kansas, United States Scismic Inc Full time
Job Overview

Scismic Inc. is seeking a dedicated Microbiology Quality Assurance Manager to oversee and enhance the environmental quality protocols at our facility. This role is crucial in ensuring compliance with industry regulations and maintaining the highest standards of quality in our operations.

Key Responsibilities:
  • Lead and provide expertise in sterilization processes while addressing plant challenges and supporting method development.
  • Develop and manage testing timelines to ensure timely product and material releases aligned with organizational objectives.
  • Oversee the cleaning and disinfection protocols for the pharmaceutical site, ensuring compliance with regulatory standards.
  • Act as the primary technical contact for internal and external stakeholders during regulatory inspections and other business interactions.
  • Establish and uphold certification processes for testing methodologies and personnel qualifications.
  • Assist Quality Leadership in various activities, including testing, qualification, and compliance initiatives.
  • Monitor microbiological aspects of plant utility systems, conducting routine trend analyses.
  • Provide solutions to challenges related to environmental control, particulates, and sterilization within the site and QC Lab.
  • Ensure a safe and compliant work environment by adhering to established standards and legal regulations.
  • Maintain compliance with cGMP, 21CFR, and USP regulatory frameworks.
  • Perform additional duties as assigned.
Essential Qualifications:
  • Bachelor's Degree in Microbiology or a related scientific discipline.
  • At least 10 years of experience in a pharmaceutical quality control setting within an FDA-regulated GMP environment.
  • A minimum of 5 years in a supervisory or managerial capacity.
  • Ability to prioritize and manage multiple tasks effectively.
  • Strong organizational skills with a sense of urgency to meet deadlines.
  • Excellent communication skills, both verbal and written.
  • Proven problem-solving abilities and attention to detail.
Language Proficiency:

Fluency in reading, writing, and speaking English is required.

Physical Requirements:

The role involves various physical activities, including sitting, standing, walking, and lifting. Reasonable accommodations may be provided for individuals with disabilities.

Work Environment:

The characteristics of the work environment are representative of those encountered while performing the essential functions of this position. Accommodations may be made for individuals with disabilities to perform essential functions.

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