Senior Analyst, Quality Control
Core
Ensuring laboratory data integrity, compliance with regulatory requirements, and efficient execution of analytical testing within a biopharmaceutical QC environment.
Role type
Senior Quality Control Analyst (Analytical Laboratory)
Builds
Laboratory test results, validated methods, and compliant analytical records
Domain
Biopharmaceuticals / Analytical Chemistry
Required skills
Data integrity compliance, regulatory understanding, analytical testing execution, team coaching, process improvement, OOS investigation, 5S maintenance, method validation, equipment validation, training development
Preferred skills
Expertise in current and future analytical techniques, project leadership
Technologies
Computerized Laboratory Systems (LIMS), e-ACHIEVEs, iCANs
Responsibilities
Ensure analytical laboratory documentation and computerized systems compliance with Data Integrity policies; coach analysts on test execution performance; improve team efficiency and velocity; identify and implement improvements in analytical practice; adhere to test schedules and identify recovery paths; identify weaknesses in laboratory performance and work with management to rectify; support and initiate analytical OOS issues; maintain 5S excellence; execute and support projects through the Lab Management team; maintain precise records of all tests performed; develop and update in-house laboratory procedures; carry out verification of testing records and generation of Final CoA; lead the transfer and validation of NPI analytical test methods; lead validation of equipment for the QC Laboratory; lead and support lab-related investigations
Seniority
Senior, hands-on IC
