RESPONSIBILITIES:
Perform the role of Change Order Coordinator for the facility.
Independently facilitate the Document Change Order and Deviations including formatting, coordinating the review and approval process, tracking and routing controlled documents, and release of documents in a timely manner.
Ensure that any new documents or changes to existing documents are appropriate, justified, accurate, complete, meets Good Documentation Practices, and approved by the required functional areas according to established procedures.
Issue document numbers, lab notebooks numbers and part numbers.
Assist in drafting, formatting, editing and rewriting SOPs in support of the quality systems across the organization.
Ensure document reviews are performed periodically in a timely manner by Document Owners. Manage archiving, obsolescence and document storage.
Perform Document Control training for new and existing employees.
Support development of QA-related training materials.
Assist with training assignment and collection of training metrics in Metro.
Trend Document Control Metrics for Management Review.
Respond to queries and issues raised by Document Owners and Approvers in a timely manner.
Assist with internal and external audits.
Support the continuous improvement to the Quality Management System, with a specialty focus on document control and change order processes.
BASIC QUALIFICATIONS | EDUCATION:
Bachelor's Degree and/or an equivalent combination of education and experience.
2 years or more of experience in Quality Assurance or in Document Control, in a laboratory, medical device or similarly regulated industry.
Working Knowledge of 21CFR820, ISO 13485:2016 standard.
Experience processing changes using an electronic documentation system.
Experience with technical writing, formatting and trending of data.
Agile Document Management System experience preferred.
COMPETENCIES:
Proficient with Microsoft Office, including Word, Excel, PowerPoint, electronic document control tools and Visio.
Ability to understand QMS procedures and ability to recognize deviations from approved documented procedures
Self-starting, detail oriented, and ability to focus on task at hand
Ability to work independently with multiple departments to resolve Document Control issues
Must be able to work effectively in a fast paced, team-oriented environment
Well-developed English written and verbal communication skills
EEO:
Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans.