QC Lab Technician II

QC Lab Technician II

Requirements

• High School Diploma/GED
• Minimum of 2 years’ experience in current Good Manufacturing Practices (cGMP), Good Laboratory Practices (GLP), or medical device Quality Assurance role
• Must be able to speak, read, and write English fluently

Responsibilities

• Perform visual and analytical testing on incoming, in-process and finished goods, stability samples and product returns for compliance with established quality specifications, including pH, density measurement, spectrophotometry, gas chromatography.
• Perform environmental monitoring for RODI water system and Liquid Media manufacturing.
• Accurately document test results on QC reports, Stability Test reports, Offline Test Requests, Validations and First Article Inspections as applicable.
• Analyze data to specifications and designate as accept/reject.
• Work with manufacturing, receiving and materials personnel to complete required QC testing, documentation in a timely manner.
• Perform out-of-specification investigations, troubleshooting, and other duties.
• Prepare standards and control materials. Maintain documentation of preparation.
• Ensure that equipment is cleaned and maintained according to work instructions.
• Maintain inventory to ensure QC lab reagents and supplies are ordered.
• Assisting with preparation and performance of Liquid Media functional testing.
• Participate in continuous improvement activities (e.g. kaizen).
• Handle hazardous waste as appropriate.
• Maintain 5S of Quality Labs and Stability Chamber area when used.
• Additional responsibilities as assigned by Quality management.

Preferred Qualifications

• Experience with sampling techniques, inspection standards, or use of analytical laboratory equipment preferred.
• Experience working in an FDA regulated environment (medical device or pharmaceutical industry) preferred.
• Experience with SAP preferred.
• Excellent math skills and the ability to utilize Excel for basic calculations and graphing preferred.
• Excellent attention to detail with a high degree of accuracy and the ability to work independently and in team situations preferred.
• Excellent observation skills with a bias for ‘corrective action’ and improve work environment processes and procedures preferred.
• Demonstrated ability to make critical decisions regarding product quality or quality system compliance preferred.
• Knowledge of basic validation, equipment calibration, equipment maintenance and change requirements preferred.
• Proven capability to prioritize responsibilities and complete tasks on schedule preferred.