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 Assurance Associate at Cook Myosite Inc. performs detailed quality reviews of batch records and associated records for final dispositioning and ensures compliance with procedural and regulatory requirements.
• Review and approve documentation associated with incoming biopsies.
• Review and approve documentation associated with incoming materials
• Review and approve records and associated data in support of cGMP operation activities.
• Create batch records, product labels and performs label verification processes.
• Perform quality reviews and approvals of batch records. Responsible for dispositioning batches.
• Participate in company projects as a quality representative.
• Participate in risk assessment activities.
• Perform investigation report writing, reviewing and closing investigation reports.
• Conduct and document training events.
• Management of customer complaints.
• Authoring quality system documents.
• Perform various office-related duties; filing, scanning, and data entry.
• Promote GLP/cGMP environment and follows procedural guidelines.
• Undergraduate degree in any Life Sciences and 1-3 years’ relevant experience or 6 years direct, relevant experience in Quality Assurance to provide a comparable background
• Minimum of 3 years' experience in Quality Assurance preferred
• Knowledge of cGMP regulations and good documentation practices
• Laboratory Setting (Non-Production): General office, warehouse and laboratory setting with potential (limited) exposure to hazardous chemicals and/or harsh disinfectants while in BioSafety Level II.
• 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.