Senior Microbiology Quality Assurance Manager

1 week ago


Allendale, New Jersey, United States Minaris Regenerative Medicine Full time
About the Role

We are seeking a highly skilled Senior Microbiology Quality Assurance Manager to join our team at Minaris Regenerative Medicine. This role is responsible for overseeing and supervising the QC Microbiology team, ensuring compliance with regulatory requirements and maintaining high standards of quality.

The successful candidate will have 5-7 years of experience in microbiology, with a strong background in cGMP biotech and pharmaceutical environments. A Bachelor of Science in biological sciences or a related field is required, along with excellent verbal and written communication skills.

Key Responsibilities
  • Manage the day-to-day activities of the QC Microbiology team, including workflow adjustments, test performance, and quality compliance.
  • Develop and revise policies and procedures to support operational excellence initiatives.
  • Represent Microbiology in internal and external audits, interacting with regulatory health authorities and clients as needed.
  • Collaborate with other departments to support organizational and functional strategy.
Requirements

To be considered for this role, you must have:

  • Bachelor of Science in biological sciences or a related field.
  • 5-7 years of relevant microbiology experience in cGMP biotech and/or pharmaceutical environments.
  • Strong understanding of FDA and EMEA regulations.
  • Excellent verbal and written communication skills.
Working Conditions

This role operates within a professional office environment of a manufacturing operations plant. The employee may be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids and must utilize universal precautions with all human specimens.



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