Position Summary
The Document Control & Records Specialist will support the Quality Team and will be responsible for daily support activities related to document control and archiving.
In this role you will store, manage, and track records, while ensuring the integrity, quality, and accuracy of all documentation.
Principal Responsibilities
- Assists the documentation process using Agile and SAP systems
- Maintains controlled documentation and records, maintains documentation databases
- Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, company policies, operating procedures and processes.
- Maintains positive communication and collaborates with all levels at the site, customers, contractors, and vendors.
- Responsible for accurate data entry and maintenance of records.
- Performs other related duties and responsibilities as assigned.
- Audit support / training support
- Cross- train to support organization as needed.
- other duties as assigned
Education / Experience Requirements
- High School diploma (Associates degree prefered).
- 2 years of experience in positions that require documentation, training and records retention environment.
Specialized Skills / Other Requirements
- Proficient with Microsoft Office, including Word, Excel, Powerpoint and Outlook.
- Strong attention to detail and ability to meet deadlines.
- Effective communication skills, both written and verbal.
- Ale to work in a fast-paced dynamic environment.
- Knowledge of Quality Management Systems under ISO 13485 : 2016
- Ability to define problems, collect data, establish facts, and draw valid conclusions.
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