Senior Quality Control Associate

Target PR Range: 30-40/hr DOE

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
  
  

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The experienced professional we seek thrives in a fast paced environment, and possesses these qualifications.

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