In this role, you will perform routine sample management and support various laboratory activities at manufacturing facility. This position will focus on general lab support activities. The role involves supporting the QC operations for raw materials, drug substance, drug product, and clinical chemistry, including data management and documentation.
Job Responsibilities
Sample coordination including cross functional collaboration with internal and external labs
Receipt, processing, distribution and shipment of the following sample types:
In-Process, DS, Formulation and DP
Equipment cleaning
Stability
Raw Materials
Coordinating domestic and international sample shipments
Communication with external Contract Test Labs (CTLs)
Interact with Development teams in a GMP compliant manner
Inspect product and raw material retention samples
LIMS (LabVantage) sample logging and result entry
AQL visual inspection of drug product
Stability program support
Controlled temperature unit management, maintenance and troubleshooting
Clean room gowning
Managing/stocking of QC lab supplies
Write/revise SOPs, protocols and reports
Complete and maintain cGMP documentation for work performed
Participate in authoring quality systems records such as deviations, change controls, CAPAs.
Support non-conformance investigations
Establish and maintain a safe laboratory working environment
Education & Qualifications
Experience: Science coursework with 0-2 years of experience in a GMP QC laboratory setting, focusing on molecular biology, analytical chemistry, or microbiology.
Proficiency with Microsoft Office Programs and electronic databases (LIMS, SAP).
Excellent troubleshooting skills and the ability to communicate scientific issues clearly.
Strong written and oral communication skills and organizational abilities.
Knowledge of GMP, microbiology, aseptic techniques, and general laboratory instrumentation.
Ability to work effectively in a fast-paced, cross-functional matrix environment.
Familiarity with relevant FDA, EU, ICH guidelines, and regulations.
A desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative.