Job Title: Document Control Specialist
Job Description

We are seeking a Document Control Specialist responsible for managing document numbers, part numbers, project numbers, archival and retrieval, maintaining files and databases of all controlled and quality-relevant documents. The role includes tasks related to ongoing QA programs and ensures the efficient processing and maintenance of documents.

ResponsibilitiesIssue 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 and retrieve stored information upon request.Assist with employee training and development of QA training materials.Assist with internal audits and vendor/supplier audits.Assist in the development of documentation such as batch records and documentation supporting submissions.Write and/or implement changes to controlled documents (e.g., SOPs, Specifications, Methods) as needed.Understand, follow, and implement instructions independently, and help others understand and implement these instructions.Prioritize projects appropriately with flexibility to accommodate changing company objectives.Perform other duties as assigned.Essential Skills1+ years of experience in a Document Control or Administrative position.Experience in a highly regulated manufacturing environment.Computer literate and competent in PC-based software such as Excel, MS Word, Portable Document Format (pdf), and Adobe Acrobat Writer/Distiller.Experience with documentation, archiving, and records management (experience in regulated industry/medical device industry highly desirable).Experience as an Agile power user.Experience with electronic document management systems, MRP/ERP systems.Agile PLM experience required.Experience with Agile or MasterControl Electronic Data Management Systems.Additional Skills & QualificationsWorking knowledge of Agile database usage and change control process.Proficient in PC-based software such as Excel, MS Word, Access, PowerPoint, Portable Document Format (pdf), and Adobe Acrobat Writer/Distiller.Knowledge of ISO 9001:2000, ISO:2003, and FDA QSRs.Knowledge of internal auditing and supplier qualification and auditing is preferred.Work Environment

This is a hybrid role, with the schedule determined post-training. The work environment involves using various technologies and equipment, with flexibility in hours and shift information based on the company's needs.

Pay and Benefits

The pay range for this position is $25.00 - $29.00/hr.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:

• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)

Workplace Type

This is a hybrid position in Austin,TX.

Application Deadline

This position is anticipated to close on Mar 7, 2025.

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\n \n About Aston Carter:\n

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.

\n Diversity, Equity & Inclusion\n

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:

\n Hiring diverse talent\n Maintaining an inclusive environment through persistent self-reflection\n Building a culture of care, engagement, and recognition with clear outcomes\n Ensuring growth opportunities for our people\n

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.

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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 astoncarteraccommodation@astoncarter.com for other accommodation options.

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