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Document Control
1 month ago
Role : Document Control (QMS)
Location : Austin, TX'
Hybrid/Onsite
Duration : 6 months contract
Job Description :
working with quality support staff in proper protocols and QMS controls and functions Initiating and maintaining QMS documents and procedures.
Developing and/or adapting systems to meet quality standards, making suggestions with regards to procedures, standards, and equipment to facilitate work and to streamline processes and to maintain product quality.
Process and maintain the manual/electronic routing, tracking, distribution and retrieval of documents
Create and maintain bills of material using Agile.
Perform document control activities, including assembling batch records, assigning tracking numbers, record filing, and lab notebook issuances.
Maintain document filing system and electronic databases for archived regulatory information. Retrieve stored information upon request.
Assist with employee training and development of QA training materials.
Assist with internal audits and assist with vendor/supplier audits.
Assist in development of documentation (batch records, documentation supporting submissions)
May write and/or implement changes to controlled documents (e.g., SOPs, Specifications, Methods, etc.) as needed.
Independently understand, follow and implement instructions, including the ability to help others understand and implement these instructions.
Prioritize projects appropriately and with flexibility to accommodate changing company objectives
Other duties as assigned.
Documentation, archiving and records management (experience in regulated industry/medical device industry highly desirable).
Working knowledge of Agile database usage and change control process.
Computer proficient in PC based software such as Excel, MS Word, Access, Power Point, Portable Document Format (pdf) and Adobe Acrobat Writer/Distiller.
Knowledge of ISO 9001:2000, ISO 13485:2003 and FDA QSRs.
