Planet Pharma · 6 hours ago
Quality Control Associate
Planet Pharma is seeking a Quality Control Associate to work in their Quality analytical laboratory during the night shift. The role involves performing analytical testing and ensuring compliance with safety guidelines and GMP practices while maintaining accurate laboratory documentation.
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
Required
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
Bachelors degree
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
Preferred
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