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Documentation Specialist/Lab Tech

Location: 

N. Mankato, US

Job Family:  Research & Development
Country/Region:  United States
Documentation Specialist 

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

 

 

Pursuing an ambitious growth agenda, Coloplast develops and markets products and services that make life easier for people with intimate healthcare needs. Employing about 12,000 people and with products available in more than 143 countries, we are one of the world´s leading medical device companies. We are constantly growing our business and always looking for new ways to move forward – we explore, learn and look for new ways of doing things.

 

Visit us on Coloplast.com.

Watch the film. Follow us on LinkedIn. Like us on Facebook.

 

Coloplast is committed to a policy of Equal Employment Opportunity (EEO) which means we employ and promote individuals based on their merits, regardless of race, color, religion, sex, national origin, age, disability, veteran status, pregnancy, sexual orientation, gender identity or expression, genetic information, marital status, citizenship status, status with regards to public assistance or any other protected classification.

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