Quality Control Associate; Nights

Overview

Weekday

Shift:

- Tuesday - Friday (9:45pm - 8:15am)

Quality Control is searching for an analyst (Associate QC) to support routine testing for the QC Night Shift Team D (Tuesday-Friday from 9:45pm - 8:15am) at Rhode Island.

Ideal Candidate:
Science related degree, HPLC, Microbiology, GMP knowledge,

Nice to have:
Wet Chemistry

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

The ideal candidate enjoys tackling challenges and excels at time management with attention to detail.

• 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

• 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
• Qualified to work in the U.S. without employer sponsorship
• Commitment of a 40-hour work week (4 x 10hr shifts) in West Greenwich, RI

• OR Associate's degree and 1-2 years of Quality or Analytical Laboratory experience
• OR High school diploma/GED and 3 years of Quality or Analytical Laboratory experience

• 1-3 years of experience in GMP analytical laboratory
• Experience executing analytical /biological testing per Methods and/or Compendia
• Experience with QC analytical systems and/or Quality systems
• Self-motivated, strong organizational skills and ability to manage multiple tasks at one time with minimal supervision
• Strong communication skills (both written and verbal)
• 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
• Independent, self-motivated, organized, able to multi-task in time-sensitive environments.
• Demonstrated experience in investigations and QC processes