Quick Info
Experience Level
Entry LevelMinimum Degree
BachelorDepartment
Quality Assurance ControlJob Type
Full TimeSpecialty Skills
ChemistryMicrobiologypHConductivityUVKFFTIRTitrationsRCRAcGMPISO 9000ISO 14000LIMSEnvironmental Monitoring
About the Role
Conducting routine and non-routine chemistry and microbiological analysis of raw materials, in-process formulations, and final products to established specifications. Working independently with limited direct supervision. Following through on multiple projects and being a goal-oriented achiever. Demonstrating business-level interpersonal and organizational skills. Wearing a half-face respirator if required. Utilizing and operating laboratory equipment and instruments according to laboratory work instructions or procedures such as pH, conductivity, UV, KF, FTIR, and titrations. Performing chemical tests requiring manual dexterity and sensory discrimination as these tests involve measuring, weighing, and other precise tasks. Completing Resource Conservation and Recovery Act (RCRA) training. Understanding and following written and verbal instructions. Understanding and following Quality Control test methods or compendia methods (USP, EP, BP, JP, or ACS) and EXCIPACT standards. Supporting department management and performing defined tasks to comply with and maintain the site’s ISO 9000/1400 certification and all regulatory requirements. Initiating operation shutdowns and notifying management if questions regarding compliance or issues requiring additional attention arise. Regulatory requirements include, but are not limited to, cGMPs, EPA, OSHA, DEA, DOT, and other applicable local, governmental, and company guidelines. Calculating and generating data for compliance to specifications and reporting results. Performing technical review of lab data forms such as water, environmental monitoring, and direct measure analysis. Calibrating and maintaining lab equipment. Entering results and raw data for tested materials or products in LIMS (Laboratory Information Management System) as needed. Conducting investigative analysis to support investigations, complaints, or instrument troubleshooting. Performing environmental monitoring duties, which require gowning into cleanrooms and collecting air and surface samples while in cleanroom environments. Reviewing for discrepancies in data, manufacturing COAs, COCs, and performing data verification in accordance with company procedures. Applying appropriate disposition labels to materials (accepted, rejected, etc.). Handling hazardous materials using all appropriate or mandatory safety PPE and safety equipment. Completing documentation in a legible manner and reviewing for accuracy. Performing other duties as assigned.
Similar Jobs
T
QC Scientist I (12 hour Night Shift)
Thermo Fisher Scientific
📍 Greenville, NC
Quality Assurance ControlEntry LevelBachelorEnvironmental MonitoringAseptic Technique+1 more
Posted 3 weeks ago
S
Quality Analyst
STERIS
📍 Brooklyn Park, MN•$123 - $123
Quality Assurance ControlMid LevelBachelorISO 9001ISO 13485+9 more
Posted 3 weeks ago
S
Quality Analyst
STERIS
📍 Spartanburg, SC•$123 - $123
Quality Assurance ControlEntry LevelBachelorISO 9001ISO 13485+7 more
Posted 3 weeks ago
S
Quality Analyst
STERIS
📍 Libertyville, IL0
Quality Assurance ControlMid LevelBachelorISO 13485FDA 21 CFR Part 820/211+7 more
Posted 3 weeks ago