Quality Control Analyst
Core
Perform biochemical analyses on products, in-process materials, and stability samples to support lot release and quality programs for biopharmaceuticals.
Role type
Quality Control Analyst (Laboratory)
Builds
Biopharmaceutical products and therapeutic proteins
Domain
Biopharmaceuticals / Biochemistry
Required skills
Biochemical analysis, GxP compliance, Laboratory safety, SOP development, OOS investigation, Method validation, Analytical method development, Process improvement
Preferred skills
Independent work, Time management, Team collaboration
Technologies
Electronic laboratory systems, GxP systems
Responsibilities
Conduct testing on in-process, product, stability, and research samples; Review test results to ensure compliance and report anomalies; Perform OOT, atypical, and OOS investigations; Write and revise control test procedures and SOPs; Maintain efficient processes for commercial testing; Assist in method validation and transfer from R&D.
Seniority
Entry to Mid-level, hands-on IC