Cook Medical ยท 1 month ago
Quality Control Associate I
US-PA-Pittsburgh
Full-time
Onsite
Entry Level
1+ years expCook MyoSite, Inc. is committed to making regenerative medicine a part of everyday medicine. The Quality Control Associate I will support the development and maintenance of methods for sampling, testing, and evaluating products and materials to ensure quality and compliance with standards.
HardwareManufacturingMedical Device
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 differentiation, 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
Qualification
Required
Undergraduate degree in 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
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
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
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
Company
Cook Medical
Cook Medical is a medical device company that specializes in designing, manufacturing, and delivering invasive medical devices. It is a sub-organization of Cook Group.
10001+ employees
H1B Sponsorship
Cook Medical has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (3)
2023 (3)
2022 (2)
Funding
Current Stage
Late StageLeadership Team
G
Gayle Cook
Co-founder
Kelly Fischer
Senior Vice President and Chief Financial Officer
Recent News
Company data provided by crunchbase