Quality Document Specialist

NORTH AMERICAN HERB & SPICE

Mundelein, IL Job Details Full-time $22.50 - $25.50 an hour 5 days ago Benefits AD&D insurance Health insurance Dental insurance Paid time off Vision insurance Employee discount Life insurance Qualifications Microsoft Excel High school diploma or GED Manufacturing facility experience Organizational skills FDA regulations Full Job Description Position Summary North American Herb & Spice is seeking a highly organized and detail-oriented Quality Document Specialist to join our Quality Assurance team. This position is responsible for maintaining, reviewing, issuing, organizing, and controlling documentation associated with our cGMP dietary supplement manufacturing operations. The Quality Document Specialist plays an important role in ensuring that manufacturing and quality records are complete, accurate, properly controlled, readily retrievable, and maintained in accordance with company procedures and applicable FDA cGMP requirements, including 21 CFR Part 111 . The ideal candidate has exceptional attention to detail, strong organizational skills, and the ability to work closely with Quality, Production, Blending, Packaging, Sanitation, Warehouse, and other departments to ensure documentation is completed correctly and submitted in a timely manner. Key ResponsibilitiesDocument Control Maintain the company's controlled Quality Management System documentation, including SOPs, work instructions, forms, specifications, logs, policies, and related quality documents. Issue, distribute, track, revise, archive, and retrieve controlled documents. Ensure only current and approved versions of controlled documents are available for use. Maintain appropriate document revision histories and approval records. Ensure obsolete documents are properly removed from circulation and archived. Maintain organized electronic and physical quality records. Assist with periodic review of controlled documents to ensure they remain current and accurate. Batch Production Documentation Receive, organize, review, and maintain completed batch production records. Verify that required manufacturing and quality documentation has been returned and properly assembled into the appropriate batch record package. Identify missing documents, signatures, dates, entries, or other documentation deficiencies and coordinate their resolution with the appropriate department. Help ensure batch records are complete and properly maintained prior to final Quality review and disposition. Maintain appropriate controls to prevent the loss, damage, alteration, or unauthorized removal of production records. Master Manufacturing Records & Quality Documents Assist with the preparation, formatting, issuance, revision, and control of Master Manufacturing Records (MMRs) . Maintain approved specifications for raw materials, components, packaging materials, labels, and finished products. Assist Quality personnel with document updates resulting from formula, process, packaging, equipment, or regulatory changes. Ensure superseded versions are appropriately archived and removed from active use. Good Documentation Practices Monitor documentation for compliance with company Good Documentation Practices (GDP) . Review records for legibility, completeness, proper corrections, signatures, initials, dates, and other required information. Help identify recurring documentation errors and communicate trends to Quality management. Assist with employee training and reinforcement of proper documentation practices. Promote the principle that manufacturing activities must be documented accurately and contemporaneously. Training Records Maintain employee cGMP, SOP, GDP, safety, and job-specific training documentation as assigned. Track required training associated with new or revised procedures. Follow up with department managers regarding incomplete or overdue training. Maintain organized and readily retrievable training records. Quality Systems Support Assist the Quality Assurance department with documentation associated with: Deviations Nonconformances Corrective and Preventive Actions (CAPA) Change controls Complaints Supplier documentation Equipment records Calibration and maintenance documentation Cleaning and sanitation records Laboratory and testing documentation Assist with document retrieval during FDA inspections, customer audits, certification audits, and internal audits. Support Quality management with special projects and continuous-improvement initiatives. Qualifications High school diploma or equivalent required; associate's or bachelor's degree preferred. Previous experience in Quality Assurance, document control, manufacturing administration, or a regulated manufacturing environment strongly preferred. Experience in the dietary supplement, pharmaceutical, food, cosmetic, or medical-device industries is a plus. Familiarity with cGMP requirements and 21 CFR Part 111 preferred. Understanding of Good Documentation Practices preferred. Strong Microsoft Word, Excel, Outlook, and general computer skills. Ability to learn electronic document management and quality systems. Excellent written and verbal communication skills. Strong organizational and filing skills. Ability to manage multiple priorities and meet deadlines. Key Competencies The successful candidate will demonstrate: Exceptional attention to detail Strong organizational and follow-through skills Accuracy and consistency Ability to identify documentation discrepancies Ability to maintain confidential information Strong sense of ownership and accountability Ability to work independently while collaborating across departments Comfort following highly structured procedures Ability to respectfully follow up with employees and managers regarding missing or incomplete records What Success Looks Like A successful Quality Document Specialist ensures that: Batch records are complete, organized, and readily retrievable. Controlled documents are current and properly approved. Production documents are properly safeguarded. Documentation errors are identified and corrected promptly. Training documentation remains current. Quality records can be retrieved quickly during audits or inspections. Documentation throughout the facility consistently meets company GDP and cGMP expectations. Why Join North American Herb & Spice? North American Herb & Spice has been producing innovative natural health products for more than 30 years. We are committed to quality, integrity, continuous improvement, and producing products that meet high standards for our customers. The Quality Document Specialist will have an important role in protecting the integrity of our manufacturing records and supporting the Quality systems that help ensure our products are manufactured consistently and in compliance with applicable requirements. North American Herb & Spice is an Equal Opportunity Employer.

Pay:

$22.50 - $25.50 per hour Expected hours: 40.0 per week

Benefits:

AD&D insurance Dental insurance Employee discount Health insurance Life insurance Paid time off Vision insurance

Work Location:

In person