QC Technician 2nd Shift (2:00pm-10:30pm)

• 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 company policies.
• Able to take responsibility for actions and work under own direction.
• Able to work well within a team and communicate mutual needs and support for team success.
• Able to communicate clearly.
• Able to write and report data clearly and accurately.
• Abe to ask questions when problems arise.
• Strong desire to learn new tasks.
• Able to manage time and organize day based on communicated priorities.
• High standards for quality and quantity of work.
• Follow instructions and procedures to ensure Coloplast continues to make high quality, safe, and effective products for our end users and to ensure compliance and safety obligations are met. 
• Able to adapt and respond to change (shows respect and sensitivity towards cultural and religious differences, adapts to changing circumstances)
• Able to work in a high pace environment in order to ensure production schedule is maintained.
• Able to set personal goals for work and work to accomplish those goals.
• Other duties as assigned.

 

Basic Qualifications

• High school diploma or equivalent
• Able to prioritize multiple tasks while maintaining routine responsibilities.
• Able to read and understand SDS