The Quality Assurance Specialist supports daily Quality Assurance and compliance operations across manufacturing, distribution, and biobank facilities, ensuring products, processes, raw materials, and finished goods consistently conform to corporate Mars QMS requirements, ISO 9001, USDA, CFIA, and biobanking standards.
The Target Pay Range for this position is $63,000 to $79,000 annually.
- Perform thorough daily review and verification of BPRs/product release records, standard operating logs, and testing documentation against physical manufactured products to ensure data integrity, completeness, and adherence to GDP.
- Approve final product release, ensuring inspection/verification of product labeling, packaging, and storage conditions is completed prior to approval.
- Initiate, investigate, and document OOS results, process deviations, customer complaints, and nonconformances.
- Assist in root-cause analyses (RCA) investigations alongside cross-functional teams (QC, R&D, Production, Operations, Warehouse) and ensure effective corrective and preventative actions (CAPA) using established problem-solving tools.
- Track CAPA milestones within the EQMS to ensure timely implementation, closure, and verification of effectiveness.
- Bachelor's degree in Life sciences discipline (Biology, Chemistry, Biochemistry), Medical Technology, Biomedical Engineering, or an applicable technical field.
- Nice to have: experience in a regulated diagnostic, manufacturing or life science laboratory environment (e.g., IVD, medical device, biotech, or ISO accredited testing facility)
