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:- 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
Basic Qualifications:- Master's Degree OR
- Bachelor's Degree and 2 years of Quality experience OR
- Associate's degree and 6 years of Quality experience OR
- High school diploma/GED and 8 years of Quality experience
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