Job Title: Quality Control Microbiology Senior Analyst

Job Description

We are seeking a Quality Control Microbiology Senior Analyst to perform testing and monitoring activities in support of the start-up and operation of the QC Microbiology laboratory and manufacturing areas. This is a 6-month contract role.

Responsibilities

• Demonstrate company values as part of a high-performing, people-focused, inclusive, and collaborative organization.
• Perform and review routine Quality Control laboratory work, including environmental monitoring, clean utility sampling and testing, microbiological material qualification and maintenance, bioburden testing, endotoxin testing, compendial testing, and container closure integrity testing.
• Generate and revise Quality Control documents according to established document management processes.
• Assist in the development of training materials and independently deliver training to staff for QC programs, systems, and processes.
• With management oversight, execute qualification/validation activities for QC laboratory equipment, instruments, and systems.
• With management oversight, execute internal and external method establishment (e.g., qualify, validate, verify, transfer) protocols to ensure QC readiness for production activities.
• Initiate and support microbial excursion investigations related to manufacturing plant monitoring programs (e.g., environmental monitoring, aseptic gowning, utility monitoring) through collaboration with other functions (Engineering, Manufacturing, MSAT).
• Apply and advance Operational Excellence/LEAN philosophy within the QC laboratories to ensure continuous improvement across all programs, processes, and systems.
• Prepare, ship, and track samples to outside testing laboratories.
• Provide additional support within the Quality organization, as needed.

Essential Skills

• Bachelor’s degree in Biochemistry, Molecular and Cellular Biology, Immunology, Biology, or other life science with 2+ years of experience working in a cGMP regulated QC environment.
• Experience with microbiology, quality control, environmental monitoring, laboratory practices, aseptic technique, chemistry, and cGMP.
• Proficiency in endotoxin testing, bioburden testing, raw material sampling, release testing, clean utility monitoring, TOC, LIMS, and QMS.
• Understanding of Operational Excellence/Continuous Improvement philosophies with practical application in a regulated laboratory environment.

Additional Skills & Qualifications

• Quality Control experience in an FDA-regulated industry supporting cGMP manufacturing areas.
• Previous experience working in laboratory and/or facility startup in a cGMP setting.
• Experience working in a clean room environment.
• Experience in cGMP cell and gene therapy manufacturing and/or testing facility.
• Experience implementing a Laboratory Information Management System along with associated processes and documents