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Documentation Specialist
3 weeks ago
- This role is responsible for maintaining the periodic review program for the site to ensure compliance.
- This role requires the coordination, review, and revision of cGMP Documents which include Standard Operating Procedures (SOPs), Work Instructions (WI's), FORMS, Job Aids (JA's), Specifications, Test Methods, and Manufacturing Batch Records.
- Monitor the periodic review program to ensure schedule adherence and timely completion of other assigned duties as applicable.
- Collaborate with functional areas to ensure timely completion of periodic reviews.
- Revise and process documents in eDMS.
- Document all activities to meet cGMP requirements.
- High school diploma or equivalent required.
- 1-3 years of proven experience, or equivalent combination of education and experience required
- Experience in quality, manufacturing, and/or GMP environment required.
- Prior experience within Microsoft Office and eDMS (or other applicable documentation system)
- Well-organized, detail-oriented, and strong time management skills
- Understanding of cGMP quality systems (e.g. change management and driving GDP within all documentation and records).
- Strong formatting skills in Microsoft Office
- Ability to work in an environment of change
- Ability to work independently and results-driven
- Ability to read, write, and communicate in English
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St Louis Park, United States Bridgewater Bank Full timeWe are seeking an experienced and detailed oriented Loan Documentation Specialist to join our Loan Administration at Bridgewater Bank in St. Louis Park. In this role, you will perform a variety of functions associated with the origination of new commercial and consumer loans and renewals/modifications of existing loans. This position requires responsiveness...