100% Onsite - Rhode Island
Urgent backfill of AMAGJP00015468 (scrubbed resume attached)
Urgent role shortlisting EOD Tuesday 7/28
Standard 8-5 local hours
The role will be on-site based out of *** Rhode Island and will work under the mentorship of the front-line manager. The Bioanalytics team provides analytical expertise in testing the following: in-process, release and stability samples. The laboratory employs a variety of test methodologies that use sophisticated equipment including: HPLC/UPLC, capillary electrophoresis and general chemistry methodologies such as: Appearance, Color, Clarity, pH, Osmolality, Polysorbate, Protein Concentration, and Sub-Visible Particle testing.
Responsibilities include the following:
" Follow safety guidelines, cGMPs (Good Manufacturing Practices) and other applicable regulatory requirements
" Generate complete, accurate, and concise laboratory documentation using electronic systems and laboratory notebooks
" Ensures that facilities, equipment, materials, organization, processes, procedures and products follow cGMP practices and other applicable regulations
" Operate laboratory equipment and instrumentation
" Performs review and approval of assays, documents and records
" Supports Continual Improvement initiatives
" Alerts management of quality, compliance, supply and safety risks
" Participate in laboratory investigations
" Perform general laboratory housekeeping activities
" Completes required assigned training to permit carry through of required tasks
" Performs additional duties as specified by management
Preferred Qualifications
" 1-2 years experience in HPLC/UPLC, capillary electrophoresis and general chemistry methodologies such as: Appearance, Color, Clarity, pH, Osmolality, Polysorbate, Protein Concentration, and Sub-Visible Particle testing
" Demonstrated experience in laboratory investigations, method validation, audits, QC processes
" Proven ability to interpret scientific data
" Self-motivated, strong organizational skills and ability to manage multiple tasks at one time with minimal direction