QC Associate I/II, Microbiology

AGC Biologics is a leading global Contract Development and Manufacturing Organization, with a deep commitment to improving life quality by bringing new biopharmaceuticals to market. Because of our dedication to building and empowering our internal teams, AGC Biologics is an innovative leader in the industry with an extensive network of cGMP facilities in the US, Europe and Asia. As such, we deliver a deep expertise, dynamic solutions and technologies, as well as customized services for the scale-up and cGMP manufacturing of protein-based therapeutics and cell and gene therapies. We forge exceptionally strong partnerships with our clients, and we never lose sight of our pledge to deliver a reliable and compliant drug substance supply, Right, On time. For more information, visit www.agcbio.com.

Summary

The Microbiology Associate I/II will be part of the Longmont Quality Control Microbiology Department.? This individual will be responsible for the testing and support of the Microbiology Laboratory in support of a cell and gene therapy Contract Manufacturing facility.???

Responsibilities include routine Quality Control laboratory activities in support of GMP testing, and execution of laboratory maintenance activities.?

This person is responsible for, but not limited to, aspects of the following programs as directed:?

• Environmental Monitoring (Air Viable, Total Air Particulate, Surface Viable)?
• Product Testing (Bioburden, Endotoxin)?
• Raw Material Testing (pH, Osmo)?
• Microbiology support programs (Media/Culture Qualification, Microbial ID, Freezing of in-house organisms)?
  

Principal Responsibilities

• Aseptic technique in all testing and sampling
• Knowledge of microbiology
• Effectively communicate on a timely basis with management and team members
• Data entry, data analysis, and other quality systems such as change control, deviations, excursions and CAPA's
• Participate in test method transfers, qualifications and validations?
• Assist with the generation of SOPs related to test methods and product release
• Adheres to all safety requirements?
• Participate in Operational Excellence programs (5S, Kanban, continuous improvement)?
• Assist with receipt of materials, stocking of laboratory areas, and ordering of laboratory consumables
  

Knowledge, Skills & Abilities

• Knowledge and experience in cGMP and the regulatory requirements for pharmaceuticals is preferred
• Strong analytical, technical writing, communication, and data management skills
• Ability to stand, reach, bend, twist, squat, and move freely in a controlled environment while gowned
• Knowledge and proficiency with Microsoft Office
  

Education/Experience

• Degree in Microbiology, biology or other scientific discipline
• 0-2+ years of relevant industry experience desired
  

Compensation range for this position: $23.32-$43.13/hr depending on experience

AGC Biologics offers a highly competitive compensation package and a friendly, collaborative culture that values personal initiative and professional achievement. AGC Biologics is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, ancestry, color, family or medical care leave, gender identity or expression, genetic information, marital status, medical condition, national origin, physical or mental disability, political affiliation, protected veteran status, race, religion, sexual orientation, or any other characteristic protected by applicable laws, regulations and ordinances.