Quality Control Associate Role at Cook Medical USA
The Quality Control Associate I position at Cook MyoSite, part of Cook Medical careers, offers an excellent opportunity for life science graduates and professionals seeking a hands-on quality control job in regenerative medicine. This full-time, on-site role in Pittsburgh, PA focuses on laboratory testing, cGMP compliance, and quality assurance activities supporting advanced cell-based therapies.
Job Details:
- Job Role: Quality Control Associate I
- Location: Pittsburgh, Pennsylvania, USA
- Job Type: Full Time | On Site
- Industry: Regenerative Medicine / Biotechnology
- Experience Level: Entry to Mid-level (1–3 years)
About the Company:
Cook MyoSite, Inc. is part of the globally respected Cook Group and plays a vital role in advancing regenerative medicine. The company focuses on autologous muscle-derived cell technology for treating muscle-related disorders. As part of Cook Medical careers, Cook MyoSite provides employees the opportunity to contribute to life-changing therapies while growing professionally in a quality-driven, ethical work environment. Explore more quality control job offers.
Educational Requirements:
- Undergraduate degree in Life Sciences, Microbiology, Molecular Biology, Biotechnology, or Engineering
OR - Minimum 6 years of direct, relevant experience in an analytical testing laboratory
Key Responsibilities of Quality Control Associate Role:
- Perform quality control sampling and testing for identity, strength, quality, and purity
- Conduct assays including DNA isolation, mycoplasma, endotoxin, desmin, and myogenic differentiation
- Execute lot testing and support nonconformance investigations
- Prepare QC documentation, quality plans, and reports
- Support method validation and evaluation projects
- Maintain laboratory and cleanroom environments within alert limits
- Perform cell culturing for lot testing and research activities
- Ensure compliance with company quality, safety, and regulatory standards
Skills Required for Quality Control Associate Role:
- Strong understanding of laboratory testing procedures
- Basic knowledge of cGMP, 21 CFR Part 11, and biopharmaceutical regulations
- Experience in cell culture and analytical testing
- Excellent analytical, problem-solving, and critical-thinking skills
- Proficiency in Microsoft Office tools
- Strong written, verbal, and interpersonal communication skills
- Ability to work independently and collaboratively under minimal supervision
Benefits of the Quality Control Associate Role:
- Opportunity to work in cutting-edge regenerative medicine
- Hands-on experience in a regulated quality control environment
- Career growth within globally recognized Cook Medical careers
- Skill development in QC testing, compliance, and validation
- Inclusive and equal opportunity workplace culture
