Senior Quality Control Associate

Target PR Range: $19–23/hr, depending on experience. The role is on-site in Rhode Island and works under the mentorship of the front-line manager.

About the role

The Bioanalytics team provides analytical expertise in testing in-process, release, and stability samples. The laboratory employs a variety of test methodologies using 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.
• Ensure that facilities, equipment, materials, organization, processes, procedures, and products follow cGMP practices and other applicable regulations.
• Operate laboratory equipment and instrumentation.
• Perform review and approval of assays, documents, and records.
• Support continual improvement initiatives.
• Alert management of quality, compliance, supply, and safety risks.
• Participate in laboratory investigations.
• Perform general laboratory housekeeping activities.
• Complete required assigned training to permit carry-through of required tasks.
• Perform additional duties as specified by management.

Qualifications

Basic Qualifications

• Master’s degree, or
• Bachelor’s degree and 1–2 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 of 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, and QC processes.
• Proven ability to interpret scientific data.
• Self-motivated, strong organizational skills, and ability to manage multiple tasks with minimal direction.

Pay

$19–23 per hour, depending on experience.