Quality Control Associate I, Microbiology

Cook MyoSite, Inc. is on a mission to make regenerative medicine a part of everyday medicine. We’re investigating our core technology, autologous muscle-derived cells, for the potential treatment of several muscle-related disorders. We at Cook MyoSite have the potential to make a difference in the lives of countless people around the world, and we also have the potential to make a difference in yours. Joining our team is an opportunity to ignite your passion, grow your potential, and define your purpose. If you’re curious, motivated by helping others, and driven by integrity, we invite you to apply.

The Quality Control Associate I, Microbiology at Cook Myosite Inc. will perform GMP testing and environmental monitoring to support lot release and in-process testing. They will aid in the development and maintenance of methods for sampling, testing, evaluating, and approving testing results for products and materials.

• Perform Good Manufacturing Practice (GMP) lot release and in-process testing for microbiology based methods such as growth promotion, gram stain, and sterility testing in support of manufacturing processes
• Perform Environmental Monitoring (EM) activities such as collecting viable air, surface EM samples, non-viable particulate samples, reading of plates and trending for EM data
• Use Laboratory Information Management Systems (LIMS) to identify samples to be analyzed and to generate analytical data and enter the data into LIMS
• Perform EM data review, trending and analysis
• Maintain instrumentation and supporting documentation in a GMP compliant manner
• Handle and work with microorganisms and maintain facility isolates
• Recommend and establish different methods for performing Quality Control Microbiology tasks

• Support in maintaining cleanroom environment below alert limits by participating in and following established cleaning practices and cleanroom etiquette
• Conduct microbiology validation studies, assay qualifications and special projects as assigned
• Support interdepartmental communications when outside testing is required
• Troubleshoot assay methods and equipment
• Cleaning and General maintenance of side labs
• Aid in activities related to monthly inventories and removal of expired products
• Assist in the investigation of nonconformance activities with additional testing and evaluation activities as needed
• Author quality system records such as deviations and CAPAs
• Maintain regular and punctual attendance
• Must maintain company quality and safety standards

• Bachelors degree in Microbiology or related experience, plus 1-3 years lab experience
• Must be able to work aseptically
• Previous experience with monitoring production environments preferred

• Strong analytical and communication skills (including technical writing) as well as sound judgment, with the ability to work effectively with others
• Computer efficiency as well as strong scientific and organizational skills
• Ability to work in a high paced team environment, meet deadlines and prioritize work from multiple projects

Physical Requirements:

• Ability to conduct and hear ordinary conversation and telephone communication.
• Must be able to work extended hours beyond normal work schedule to include, but not limited to, evenings, weekends, extended work hours and/or extra work hours, sometimes on short notice as required.
• Ability to work under specific time constraints.
• Must be able to sit at desk, in meetings and/or work on a computer for long or extended periods of time.
• Visual and manual acuity for working with computers and equipment.
• Ability to spend majority of day standing in laboratory setting or sitting at/working in a biological safety hood with potential (limited) exposure to hazardous chemicals and/or harsh disinfectants while in BioSafety Level II or other labs.
• Physically capable of standing, walking, stooping, kneeling, crouching, climbing steps and ladders, reaching, twisting and bending on occasion with or without reasonable accommodations.
• Must be able to lift/push/pull up to 50 pounds on an occasional basis with or without reasonable accommodations.
• Must be capable of performing PPE gowning procedures on a frequent basis to enter BioSafety Level II including but not limited to safety glasses, lab coat, gloves, specialized clothing including laboratory scrubs (pants and shirt), appropriate shoes, and facial mask (if required) on a regular basis

Employee that does not interact with Healthcare Professionals
Compliance with all policies of the company including without limitation the Cook Employee Manual, Cook Code of Conduct, Quality System Manual, Cook Electronic Information Policy and HIPAA regulations

At Cook MyoSite, we don’t just accept difference — we celebrate it, we support it, and we thrive on it for the benefit of our employees, our products, and our community. Cook MyoSite is proud to be an equal opportunity workplace.
This job description features the essential and critical functions of the position described and is not an exhaustive list of tasks and/or responsibilities. This may be subject to change at any time due to reasonable accommodation or other reasons.