Job: Associate Scientist I/Associate Scientist II, Medicago USA, Durham, NC
Under the supervision of the QC Biochemistry Supervisor, the candidate is responsible for the coordination and execution of activities for quality control programs including the following responsibilities:
• Responsible for performing Biochemistry and analytical testing (i.e. ELISA, UPLC, SDS-PAGE) for stability, routine, non-routine, method development, and method validation.
• Perform data entry and record issuance tasks supporting QC programs
• Assist in the establishment and ongoing management of QC programs
• Perform data and document review
• Responsible for maintaining laboratory equipment in accordance with QC procedures
• Assist with technical writing of procedures, protocols and reports
• Organize, assemble, and route documentation to support QC document review and approval as required by Quality Systems Management
• Prepare and provide timely and accurate reports and assessments of assigned project(s) and quality metrics to the QC Management
• Participates in problem solving exercises to identify the potential root causes.
• Author deviations, investigations, and change controls.
• Experience with working in a cGMP environment
• Experience with quality programs associated with biopharmaceutical laboratory operations
• Excellent communication skills both written and oral required
• Experience with Waters HPLC/UPLC and Empower software preferred
• Experience with ELISA, SDS-PAGE, and other plate based assays preferred
• Must be well organized and have the ability to multitask in a fast paced environment
• Attention to detail and good documentation practices
• Self-starter, results-oriented individual with ability to organize and analyze data
• Proficiency with MS Office applications required
• Experience with enterprise applications (example: LIMS, Trackwise, Master Control) preferred
• The employee is required to stand, up to 6 hours a day; walk; reach with hands and arm and stoop, kneel, crouch, or crawl
• The employee must occasionally lift and/or move up to 20 pounds