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Document Control Specialist
Employment Type:
Contract
Industry: Administrative Support
Job Number: 20777
Pay Rate: $32-34/hr depending on experience
Job Description
Document Control Specialist I
Position Summary
The Document Control Specialist I is responsible for executing change control processes to ensure the standardization, accuracy, and completeness of documents prior to release. This role represents Quality Assurance (QA) and collaborates with cross-functional departments to provide quality system guidance. The Document Control Specialist I also maintains the MasterControl document management system and supports continuous improvement initiatives within the quality system.
Essential Duties & Responsibilities
Position Requirements
Education & Experience
Technical Skills
General Skills
Position Summary
The Document Control Specialist I is responsible for executing change control processes to ensure the standardization, accuracy, and completeness of documents prior to release. This role represents Quality Assurance (QA) and collaborates with cross-functional departments to provide quality system guidance. The Document Control Specialist I also maintains the MasterControl document management system and supports continuous improvement initiatives within the quality system.
Essential Duties & Responsibilities
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Create and maintain Document Control quality system procedures and quality documents.
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Maintain controlled copies of quality documents in both hard copy and electronic databases.
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Index, file, archive, and manage off-site storage of controlled quality and corporate records.
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Execute change control processes, ensuring accuracy, completeness, and compliance prior to release.
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Collaborate with cross-functional teams to ensure timely processing of protocols, reports, and validation documentation.
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Provide guidance on good documentation practices (GDP) and ensure compliance with regulatory requirements.
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Support maintenance of design history files, device master records, and technical files.
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Assist Operations with part number control and bill of materials (BOM) maintenance in the ERP system following approved change orders.
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Provide training to employees on using MasterControl for document and change order processing.
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Conduct QA reviews of calibration and preventive maintenance records, including scanning and archival.
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Facilitate document retrieval and support during internal and external audits or regulatory inspections.
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Participate in continuous improvement projects related to document control and quality systems.
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Perform other duties as assigned.
Position Requirements
Education & Experience
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Associate degree or higher preferred.
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1–2 years of document control or related experience preferred.
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Experience in an FDA-regulated or IVD (In Vitro Diagnostics) industry preferred.
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Experience with MasterControl and ERP systems a plus.
Technical Skills
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Proficient in Microsoft Office (Word, Excel, Outlook).
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Knowledge of Document and Change Control electronic systems (preferably MasterControl).
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Familiarity with cross-functional collaboration (Manufacturing, Operations, Quality, etc.).
General Skills
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Detail-oriented, organized, and self-directed.
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Strong time management and prioritization skills in a fast-paced environment.
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Excellent communication and interpersonal skills.
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Demonstrates professionalism and the ability to build positive working relationships.
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Ability to complete tasks accurately and thoroughly under minimal supervision.
Hours: 8am-5pm
Pay $ 32-34.00
#MS-CBMFG
Meet Your Recruiter
Jennifer Lyons
Senior Recruiter & Payroll Specialist
Jenni comes to Marquee Staffing with an extensive background in accounting and business administration. She has been a valued member of the Marquee Staffing team since 2015, bringing years of experience, dedication, and a passion for connecting talented individuals with the right career opportunities. Jenni earned her Bachelor’s Degree in Business Management from Oklahoma State University, further strengthening her knowledge and expertise in business and leadership.
Outside of work, Jenni enjoys spending quality time with her family and dogs, as well as working out. She also loves pampering herself and enjoying beauty and self-care routines. Jenni believes in maintaining a healthy balance between a rewarding career, family, and making time for the things that bring her joy.
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