QA Document Control
QA Document Control
Posted on :
18-10-2024
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Job Description
Role : QA Document Control
Location : Austin TX
Duration : 6 months contract
Location : Austin TX
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
Employment Type
Full Time
Key Skills
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