QC technologist

The QC Technologist II is responsible for the execution of a broad range of bench test procedures used in raw material qualification, the testing of finished goods prior to release, the investigations of product performance and for conducting routine validation studies, as well as assisting with timely product release and routine maintenance of the Quality Control (QC) laboratory. The QC Technologist II works with the QC and Quality Assurance (QA) to resolve product performance issues and maintenance of the documentation files of approved QC Standard Operating Procedures (SOP) in compliance with Food and Drug Administration (FDA) Good Manufacturing Practices (GMP) (QSR) regulations, ISO-9001 and EN46001, EN13485 Standards.
Perform testing of biological raw materials and finished goods per relevant SOP; release acceptable product
Perform testing for product validation and process validation on existing products; publish data accordingly
Perform testing and prepare reports as required for investigation of non-conforming material and for performance evaluations
Coordinate, perform testing and prepare reports for various special projects as deemed necessary by technical review team
Responsible for analyzing data and tracking relevant trends
Maintain proper laboratory housekeeping and supply levels in the QC laboratory
Document all test results and maintain product release records (including electronic records)
Perform QC record audits as required under standard QA procedures
Work with the QC Coordinator to ensure the laboratory is always equipped to handle routinely scheduled testing and anticipated increases in test schedule
Document existing product/process validation test results and maintain validation test results (including electronic records)
Maintain product testing database and perform relevant statistical analyses including trend analysis
Ensure optimal laboratory supply levels and optimal laboratory equipment operation in the QC laboratory
As required, work cross-functionally to investigate and resolve non-conforming material and performance issues
Ensure and maintain compliance with the Company's quality system requirements through training and adherence to policies, procedures and processes
Other duties as assigned

Top Three Skills: QC labratory experience, testing, GMP experience

Qualifications: GMP experience and detail oriented
2 years experience minimum
okay with biological samples, testing blood can be non-degreed
chemistry background is ok

About Aerotek: Aerotek, headquartered in Hanover, Md., is a leading provider of technical, professional and industrial staffing services. Established in 1983, Aerotek is an operating company of Allegis Group, the largest provider of staffing services in the U.S. Aerotek operates a network of more than 200 non-franchised offices throughout the U.S., Canada and Europe. For more information, visit aerotek.com. Aerotek is acting as an Employment Agency in relation to this vacancy.