Quality Control (QC) professionals are responsible for testing, inspecting, analyzing, and documenting products, materials, and processes to ensure they meet established quality, safety, regulatory, and customer requirements.
In pharmaceutical, biotechnology, and medical device environments, QC roles typically support GMP compliance, laboratory testing, raw material release, analytical methods, validation, SOPs, and quality documentation. They work closely with Quality Assurance, Manufacturing, R&D, and Regulatory teams to identify issues and maintain product quality.
- 75% Executing experiments and procedures as detailed by lab manager and staff.
- 25% Writing /revising documents procedures and validation documentation.
Education and Experience Requirements:
- Essential: Minimum Bachelor's degree in Chemistry/Biology/Biochemistry.
- Desired: Experience in a laboratory environment is preferred.
- Experience with Matlab or other chemometric software.
- Assist in document authoring/ revision and approval (protocols, test methods, SOPs) and other routine laboratory activities supporting the lab as 079 activities are completed by the biochem team.
- This role supports the daily operations of the QC Raw Materials department, whose primary responsibility is the testing and release of raw materials for GMP use in manufacturing.
- In this role, the primary responsibility for the individual in this position is to assist in instrument/method projects with some supervision. The projects may require attending meetings based on the specific project, document writing/revising to ensure compliance with regulations and quality control practices.
- The person in this role may also be asked to revise documents to assist in the daily operations of the team.