The QC Documentation Specialist manages, organizes, and verifies critical quality records, Standard Operating Procedures (SOPs), and compliance documents. You will ensure that all documentation meets strict regulatory standards, track document lifecycles, and supports cross-functional teams with audits and reviews.
Job Requirements:
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Document Creation: Data input for quality inspections
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Document Control: Administer the document control system, ensuring all SOPs, batch records, and quality manuals are accurately versioned, formatted, and archived.
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Review & Verification: Audit completed QC data, test results, and batch records for accuracy, completeness, and adherence to regulatory guidelines.
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Compliance: Enforce Good Manufacturing Practices (GMP) and internal quality standards across all documentation.
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Audit Support: Assist in preparing for internal and external regulatory audits by pulling files, verifying signatures, and organizing compliance records.
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Training Support: Maintain updated employee training matrices and ensure staff have signed off on the latest document revisions.
Other duties as assigned.
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Required Experience / Education:
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Associate’s or Bachelor’s degree in a scientific, business, or related field (or equivalent work experience).
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2–4 years of experience in quality control, document administration, or regulatory compliance within a manufacturing environment.
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Proficiency with an Electronic Document Management Systems (EDMS) and strong working knowledge of the Microsoft Office Suite.
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Exceptional organizational skills with a keen eye for spotting data errors, typos, and missing information.
Additional Position Information:
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Primarily an office/desk environment with occasional time spent on the manufacturing floor.
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Requires the ability to sit for extended periods, operate a computer, and occasionally lift/move up to 20 lbs.
