Quality Control Associate – Night Shift

Position Title: Associate Quality Control – Night Shift

Work Location: West Greenwich, RI 02817

Assignment Duration: 12 months – possible extension

Work Schedule: Night Shift “Team D” (Tuesday-Friday or Saturday – Tuesday from 9:45 PM – 8:15 AM); 40-hour work week (4 x 10hr shifts)

Work Arrangement: Onsite

Position Summary:

Quality Control is searching for an analyst (Associate QC) to support routine testing for the QC Night Shift “Team D” at our organization's Rhode Island site.

This person will be responsible for working in the Quality analytical laboratory, using GMPs and GDPs to execute analytical testing.

Background & Context:

• The position is open to supplement additional workload on the team within the Quality Control analytical laboratory.

Key Responsibilities:

• Performing analytical testing including time sensitive samples from Manufacturing (Titer/ MMV/ Mycoplasma/ Endotoxin/ Bioburden/ TOC/ Conductivity), Centralized Raw Material testing (compendial testing & microbiology), Environmental Monitoring and Critical Utilities, Sample Receipt and Aliquot.
• Ensures that facilities, equipment, materials, organization, processes, procedures and products comply with safety guidelines, cGMP (Good Manufacturing Practices) practices and other applicable regulations.
• Generates complete, accurate, and concise laboratory documentation using electronic systems and laboratory notebooks. Operates laboratory equipment and instrumentation.
• Performs review and approval of assays, documents and records. Supports troubleshooting and problem solving.
• Alerts management of quality, compliance, supply and safety risks. Supports TRAs and deviations, as applicable.
• Completes required assigned training to permit execution of required tasks. Performs additional duties as specified by management.

Qualification & Experience:

• Experience with analytical laboratory testing with the ability to plan and perform routine tasks with efficiency and accuracy.
• Demonstrated ability to work independently and deliver right first time results.
• Excellent communication skills (written and verbal). Must have focus on data integrity.
• Experience with analytical laboratory testing including HPLC, Microbiology, and Wet Chemistry.
• Knowledge of GMP (Good Manufacturing Practices) and GDP (Good Documentation Practices).
• Understanding and application of principles, concepts, theories and standards of GMP QC analytical laboratories.
• Understanding of biopharmaceuticals process and related unit operations.
• Strong analytical skills with the ability to collect, organize, analyze, and disseminate significant amounts of information with attention to detail and accuracy.
• High school/GED 2 years work experience or Associates degree and 6 months work experience or Bachelors degree.