Quality Control Analyst II, Microbiology

Description:

We are seeking an experienced Quality Control Microbiologist to join Mariana’s Technical Operations organization, advancing personalized medicine and radiopharmaceuticals. This person will be responsible for routine microbiological testing including environmental monitoring, environmental monitoring performance qualifications, growth promotion, bioburden, endotoxin, and sterility testing to support product release. In addition to supporting routine testing, this role will ensure that work is completed with SOPs and adheres to strict quality standards.

Illustrative Breadth of Responsibilities:

• Perform environmental monitoring and environmental monitoring performance qualifications (viable, non-viable, and surface monitoring) of classified areas and maintain database of recovered data and isolates to actively trend EM data.
• Perform bioburden, endotoxin, and sterility testing to support product release.
• Conduct growth promotion testing and release of media.
• Ensures aseptic operator qualification and process simulations are performed aseptically according to GMP compliance.
• Microbial enumeration and data analysis from microbiological testing.
• Experienced with raw material testing is considered a plus.
• Identifying, investigating, and resolving microbial action limits, Out of Specification (OOS) results, and deviations.
• Maintain laboratory equipment in accordance with internal procedures.
• Adhere to SOPs to ensure high quality standards.
• Track progress against project timelines, generate regular status updates, and communicate progress and risks to management.
• Adhere to safe laboratory practices.
• Multi-task across several projects and manage time effectively to achieve results.
• Perform other duties as assigned.

Requirements/Skills:

• Bachelor’s degree in microbiology or related field with a minimum of two years of experience working in a GMP environment in the pharmaceutical or biotechnology industry. Experience working with radiopharmaceuticals will be considered as a plus.
• Experience with cGMP and GMP regulations.
• Commitment to maintain data integrity through strict adherence to standardized procedures and relevant compliance requirements.
• Good understanding of the radiation safety regulations and guidelines is preferred.
• Comfortable handling radioactivity and follow proper ALARA (As Low As Reasonably Achievable) technique Strong communication skills, with motivation to work effectively and cooperatively with others, and to establish and maintain good working relationships.

Mariana Oncology’s Principles

• Building a Legacy
• Execution Excellence
• Courage of our Convictions