Document Control Specialist
5964 La Place Ct. Carlsbad, CA 92008 US
Job Description
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
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Meet Your Recruiter
Jennifer Lyons
Senior Recruiter & Payroll Specialist
Jenni comes to Marquee Staffing with an extensive background in accounting and business administration. Her primary focus as a talent coordinator is to ensure the inner workings of the office run smoothly and efficiently. Jenni takes pride in providing top-notch assistance to our clientele and is adept at multitasking. For instance, when it comes to the demands of processing payroll and accounts receivable as well as miscellaneous duties pertaining human resources, she handles it all with finesse.
In Jenni’s spare time, she enjoys cheering on her son at his football games. You can also find Jenni headed to a cross fit or a boot camp class, shopping or spending time with family and friends.