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Documentation Associate - Mankato, MN


N. Mankato, US

Job Family:  Quality Assurance
Country/Region:  United States

Documentation Associate - Mankato, MN 

Coloplast has a new opportunity to join the Quality team as a Documentation Associate in North Mankato, MN. . As a full time Coloplast employee, you have the opportunity to become eligible for our standard benefit package which currently includes health insurance, dental, vision, a 401K plan, and a PTO plan of 17 days per year. The Documentation Associate is ponsible for review and archiving of batch history records, release of finished product and conducting component inspections.


Major Areas of Accountability
•    Compile and review skin care batch records.  Release (or reject) product in EnterpriseOne (E1) and archive batch records.  Approve packaging master records.
•    Send Certificates of Analysis and provide required documentation to Coloplast Canada and private label customers.  
•    Inspect packaging components with respect to specifications, shelf samples and other relevant components to assure compliance.  Sample printed items for QA and Global Marketing.  Apply lot / item coli labels and specify lot status in E1.  Initiate NCRs as necessary. Re-evaluate / retest items to extend shelf life.
•    Review other quality records to ensure completeness and accuracy
•    Other duties assigned necessary to complete projects and promote efficient functioning of the QA department.


Basic Qualifications
•    High school diploma or GED equivalent
•    Computer skills in Microsoft software
•    Attention to detail
•    Capability to clearly communicate verbally and in writing 


Preferred Qualifications
•    JDE materials management systems 
•    Ability to uphold quality values and GDP/GMP in documentation review 
•    Clear understanding of cGMP documentation requirements for drug, medical device and cosmetic manufacture



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.


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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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