Coloplast has a new opportunity available in North Mankato, MN for a Documentation Specialist/Lab Tech to join our Innovation team. The Documentation Specialist/Lab Tech will coordinate documents through the Document Control systems, in support of the manufacturing process.

Major Areas of Accountability:

• Coordinates documentation between innovation, quality, engineering, marketing and sales, regulatory, and operations.
• Prepares and manages Change Request documentation.
• Assists with writing raw material and finished product specifications as well as protocols and reports for the research and development lab.
• Writes design history file documentation and assists in maintenance of the files.
• Reviews all Change Request documents submitted to confirm they are complete and correct.
• Works with other departments and facilities to develop documentation system improvements and solutions to problems.
• Follow the Quality and EHS (QEHS) Policy for the site.
• Support continuous improvement of the QEHS Management System and share any improvement ideas with appropriate staff including: drawing attention to the manager to any difficulties in understanding or following the guidelines, drawing attention to inefficiency of the system.

* Performs other related duties and special projects as required.

Essential Qualifications:

* Proficient computer skills (2 + years of Microsoft Systems: Excel and Word)
* Relevant system experience/product knowledge
* Attention to detail
* Easily adapts to changes in organizational systems and priorities

Preferred Qualifications:

* Understanding of cGMP documentation requirements for over-the-counter drug, medical device and cosmetic manufacture

Bachelor's Degree in related discipline, such as Business, Science, Technology, Engineering, Math