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Document Control Specialist
| Company | Orthofix |
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| Location | Carlsbad, CA, USA |
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| Salary | $25.72 – $33.48 |
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| Type | Full-Time |
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| Degrees | Bachelor’s |
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| Experience Level | Mid Level |
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Requirements
- High School Diploma or equivalent
- 3+ years’ experience within Document Control
- Related experience working with Quality System or technical documentation systems, preferably in an FDA regulated environment
- Working knowledge of ISO and FDA document management guidelines, regulations, and standards
- Outstanding attention to detail
- Strong interpersonal skills and ability to work with others in a positive and collaborative manner
- Demonstrated ability to work accurately, follow instructions/schedules/timelines and handle multiple priorities
- Ability to utilize multiple word-processing and database applications including MS Office applications Word, Excel, and other software applications as necessary
Responsibilities
- Coordinate the activities of Document Control, including the tracking, release, distribution, and auditing of controlled documents.
- Organize and facilitate approval process of Change Orders, including distribution and archiving of final documents whether hard copy or electronic.
- Review completeness of documentation for accuracy and consistency.
- Maintain compliance activities associated with the Quality Management System (QMS) to comply with applicable regulations.
- Reviewing completeness and processing of deviations.
- Collaborate with subject matter experts effectively to prepare controlled documents per our GDP procedures.
- Managing GTIN Database.
- Compilation of monthly document control metrics.
- Effectively follow SOPs, policies, and FDA Good Manufacturing Practices.
- Provides support for the Quality Systems and Regulatory departments during internal and external audits and actively participate in department activities.
- Support the CAPA program as needed.
- Scan, file and/or box documentation (i.e., batch records, Special Request etc.) and verify documentation for destruction, per our established procedure as applicable per site.
- Maintaining External Standards and processing of requests for updates or new purchases.
- Perform other duties as assigned.
- Assist in technical projects as needed.
Preferred Qualifications
- Bachelor’s degree preferred
- Ability to work independently
- Type 45 WPM
- Excellent Customer Service
- Problem solving Skills
- Prior knowledge and experience with electronic document management systems (DMS), learning management systems (LMS), product lifecycle management systems (PLM) or enterprise resource planning systems (ERP) is preferred
