Quality Control Associate I

Overview

Cook MyoSite, Inc., part of the Cook Group, Inc. family of companies, 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 at Cook MyoSite will aid in the development and maintenance of methods for sampling, testing, evaluating, and approving testing results for products and materials.

Responsibilities

• Performs quality control sampling and testing of materials and products for identity, strength, quality and purity utilizing assays for, but not limited to, DNA isolation, mycoplasma, endotoxin, myogenic differention, and desmin
• Performs lot testing
• Assists in the investigation of nonconformance activities with additional testing and evaluation activities as needed
• Writes quality plans and reports to QC-related activities
• Performs QC projects for validation and evaluation of methods
• Recommends and establishes different methods for performing QC tasks
• General maintenance of side labs
• Aids in activities related to monthly inventories and removal of expired products
• Cell culturing for lot testing and research
• Supports in maintaining cleanroom environment below alert limits by participating in and following established cleaning practices
• 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
• Trainability
• Must have effective verbal, written and interpersonal skills
• Excellent analytical skills with the ability to analyze situations accurately and effectively
• Must demonstrate critical thinking and proven problem-solving skills
• Must exhibit well developed skills in prioritizing, planning, organization, decision making, and time management
• Able to analyze situations or data
  
  

Qualifications

• Basic understanding of cGMP, 21 CFR Part 11, and related regulations associated with Bio/Pharmaceutical product manufacturing Ability to learn and support new systems and applications, and the ability to provide technical training to end users.
• Proficient knowledge of Microsoft Office software, and other general office equipment.
• Undergraduate degree any Life Sciences, Engineering field, Microbiology, or Molecular Biology or 6 years direct, relevant experience in analytical testing laboratory to provide a comparable background
• Minimum of 1-3 years' experience in laboratory testing environment
  
  

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.