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 primary function of the Instrument Specialist is supporting company operations by monitoring and controlling laboratory & Manufacturing instruments throughout facility.
• Maintains a solid understanding of the instruments used within the cGMP manufacturing process and final product testing.
• Provides technical support for cGMP and non-cGMP Analytical and Micro instruments associated with the manufacturing process.
• Perform in-house calibrations and preventive maintenance activities on laboratory equipment utilizing the site computerized maintenance management system (CMMS).
• Responsible for notifying Metrology Manager and System Owners of any instrument issues.
• Ensure vendors maintain instruments as it relates to the specific service being provided.
• Escort and oversee vendors throughout the facility and in the manufacturing suite.
• Assist with the evaluation and ordering of appropriate laboratory instrumentation and parts.
• Assist in maintaining all instrument procedures pertaining to Metrology.
• Aid in the organization and maintaining a preventive maintenance schedule for all instruments.
• Promotes GLP/cGMP environment and follows procedural guidelines.
• Understand and maintain up-to-date knowledge of instruments used within company.
• Support in maintaining cleanroom environment below alert limits by participating in and following established cleaning practices.
• Provide OJT training for Metrology specific to instruments utilized at company.
• Undergraduate or associate degree in engineering with at least 2 years previous experience with laboratory instruments in a manufacturing facility.
• 5+ years of operation and maintenance of analytical and laboratory instruments
• Proficient knowledge of Microsoft Office software, and other general office equipment.
• Basic understanding of cGMP, 21 CFR Part 11, and related regulations associated with Bio/Pharmaceutical product manufacturing
• Extensive knowledge of laboratory and analytical instrument operation
• Exemplifies Cook MyoSite Core Values
• Maintain regular and punctual attendance.
• Must maintain company quality and safety standards
• This position requires an ongoing commitment to upgrading knowledge, job skills and abilities in addition to competency related to all duties and responsibilities listed above.
• Ability to work in collaborative and independent work situations and environments with minimal supervision
• Maintain composure and competence under stressful situations; demonstrate flexibility and adaptability
• Must work and interact effectively and professionally with and for others throughout various levels of the global organization to achieve company goals
• Must have effective verbal, written and interpersonal skills
Full Time On Site
• 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 warehouse setting for extended periods of time, and at times work within confined areas.
• 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 a regular basis.
• 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.
Training Compliance: 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.