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Quality Control Technician 2nd Shift

3 months ago


Mankato, United States Coloplast Full time
Receiving, inspecting, and sampling incoming materials for conformance to specifications. Testing and evaluating incoming materials (raw materials), intermediate products, and finished goods to ensure they are within specification and meet Coloplast standards.

Major Areas of Accountability

Follow all EHS policies and safe practices. Follow all Coloplast polies, procedures and specifications. Follow cGMP, ISO, USP, GDP, and Coloplast requirements. Keep workstations and documentation neat and orderly. Ensure that equipment is in good working order and calibrated prior to use if necessary. Assure necessary reagents, gases, components for instruments and lab supplies are available for use. Perform QC inspector backup activities (including receiving, inspecting, sampling, and testing) Test raw materials (including physical testing, FTIR, ID/assay testing) Test intermediate and finished product Test samples for supplier certificate of analysis validations Assist chemists/microbiologist with method development/validation of test methods. Confirm materials meet established standards and specifications and release per procedures. Gather information and assist in the investigation of out of specification (OOS) results. Initiate investigations as needed. Complete Quality and EHS training as required. Coloplast employees are required to conduct business to the highest ethical and professional standards; comply with applicable laws and regulations, the Advamed Code of Ethics on interactions with Healthcare Professionals, and