Quality Assurance Associate I

4w4 weeks ago

Cook Medical

Pittsburgh, US · Full-time · $50,000 – $65,000

About this role

Cook MyoSite, part of the Cook Group, is advancing regenerative medicine using autologous muscle-derived cells. The Quality Assurance Associate I performs detailed reviews of batch records to ensure compliance with procedural and regulatory requirements, playing a critical role in final batch dispositioning.

Day-to-day activities include reviewing and approving documentation for incoming biopsies and materials, creating batch records and product labels, and performing label verification. The associate also reviews batch record data and supports cGMP operations, along with investigation report writing and customer complaint management.

The work environment is a laboratory setting with potential exposure to hazardous chemicals under BioSafety Level II. The role requires both collaborative and independent work with minimal supervision, and a commitment to maintaining GLP/cGMP standards.

Cook MyoSite offers the opportunity to make a difference in the lives of countless people through regenerative medicine. The company values integrity and passion, and expects ongoing upgrading of knowledge and skills, allowing you to define your purpose while contributing to innovative research.

Requirements

Undergraduate degree in any Life Sciences and 1-3 years relevant experience, or 6 years direct Quality Assurance experience
Minimum of 3 years' experience in Quality Assurance
Proficient knowledge of Microsoft Office software
Knowledge of cGMP regulations and good documentation practices
Ability to work extended hours including evenings and weekends
Ability to work in collaborative and independent situations with minimal supervision
Ability to work in a laboratory setting under BioSafety Level II conditions

Responsibilities

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 perform label verification processes
Perform quality reviews and approvals of batch records and responsible for dispositioning batches
Participate in risk assessment activities
Perform investigation report writing, reviewing, and closing investigation reports
Manage customer complaints