Compare your skills with the requirements for Separation Specialist and see what you need to learn
Job description:
Primary Job Objectives
Perform routine testing of release, stability and in-process samples according to relevant SOPs, AMPs, protocols and cGMP requirements, including but not limited to separation methods.
Document experiments following GDP and enter the results in LIMS.
Trending of routine testing data including release, stability and in-process data.
Participate in investigations, deviations and change control as needed.
Help in procurement of lab reagents, standards and consumables.
Participate in 5S activities and keep the lab in Audit ready mode.
Complete regular training activities within timelines in MC.
Perform analytical method transfer, verification/validation and routine analysis using various analytical techniques; including but not limited to HPLC (Titer, CEX etc.) UPLC, CE, cIEF and UV.
Author Instrument SOPs and analytical methods as needed.
Minimum Requirements
BS or MS in Chemistry, Biochemistry, Microbiology, Molecular Biology, Biological Engineering, or another related field.
Previous experience in a Quality Control/GMP environment is a plus.
Special Knowledge
Ability to accurately and completely understand and follow cGMP requirements.
Ability to author SOPs, methods, protocols/reports is a plus.
