Quality Control Senior Associate (HPLC/chemist)

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 Bioanalytic 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

Basic Qualifications    

High school/GED + 2 years’ work experience OR Associates and 6 months’ work experience OR Bachelors

Top 3 Must Have Skill Sets:       

HPLC, Quality Control, Laboratory chemistry experience