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Document Control Specialist
Our client in North Austin, TX is seeking to hire a Document Control Specialist for a long term contract!. Apply today!
Description:
The primary issue of document numbers, part numbers, project numbers, archival and retrieval, maintaining files and databases of all controlled and other quality-relevant documents of the company including lab notebooks, audit reports, SOPs, training records, design history record, all procedures and work instructions and all released product information.
What you will do:
+ Issue document numbers, part numbers and project numbers
+ Process all document and drawing changes including preparation, formatting, distribution, routing, maintenance and release to authorized users
+ 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.
Minimum Qualifications:
+ Requires associates, prefers bachelors
+ 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
Additional Skills & Qualifications:
+ Experience as an Agile power user
+ Experience in Med Device/lab space strongly preferred
+ Knowledge of internal auditing and supplier qualification and auditing is preferred.
+ Experience with Agile or MasterControl Electronic Data Management Systems is preferred.
About Aston Carter:
Aston Carter provides world-class corporate talent solutions to thousands of clients across the globe. Specialized in accounting, finance, human resources, talent acquisition, procurement, supply chain and select administrative professions, we extend the capabilities of industry-leading companies.
We draw on our deep recruiting expertise and expansive network to meet the evolving needs of our clients and talent community with agility and excellence. With offices across the U.S., Canada, Asia Pacific and Europe, Aston Carter serves many of the Fortune 500. We are proud to be a ClearlyRated Best of Staffing double diamond winner for both client and talent service.
Diversity, Equity & Inclusion
At Aston Carter, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:
+ Hiring diverse talent
+ Maintaining an inclusive environment through persistent self-reflection
+ Building a culture of care, engagement, and recognition with clear outcomes
+ Ensuring growth opportunities for our people
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email …@astoncarter.com ( …@astoncarter.com) for other accommodation options.
