ABOUT THE ROLE

The Document Control Specialist is responsible for managing, maintaining, and controlling all critical documents and records within Adept Life Sciences' nutraceutical manufacturing operations. This role ensures that all quality system documents — including standard operating procedures (SOPs), batch records, work instructions, forms, specifications, Certificate of Analysis, and regulatory filings — are accurate, current, properly distributed, and retained in compliance with cGMP regulations (21 CFR Part 111) and company quality standards. The Document Control Specialist plays a foundational role in maintaining inspection-readiness, supporting quality assurance initiatives, and ensuring that the entire organization operates from the most current and approved versions of all controlled documents.

Schedule:

6:00am

• 2:30pm

M-F KEY RESPONSIBILITIES & DUTIES

• Document Management & Control
• Maintain and administer the company's document control system, ensuring all controlled documents are properly identified, versioned, approved, distributed, and archived.
• Create, format, revise, and issue controlled documents including SOPs, batch records, work instructions, forms, labels, CAPAs, specifications, certificate of analysis, and quality agreements in accordance with established document control procedures.
• Ensure all documents follow the company's document numbering, formatting, and version control standards consistently.
• Generate Certificate of Analysis by reviewing and approving completed batch paperwork and laboratory test results.
• Generate raw material and packaging specifications from finished good specifications and technical data supplied by suppliers.
• Review and approve finished good specifications.
• File and maintain technical documentation supplied by suppliers.
• Process change requests (CRs) and change control submissions; coordinate review and approval workflows with the appropriate stakeholders.
• Maintain and update the master document register, ensuring all documents are tracked, retrievable, and reflect current approval status.
• Distribute new and revised documents to applicable departments and collect acknowledgment of receipt as required.
• Retire and archive obsolete documents in accordance with document retention policies; ensure obsolete versions are removed from active use.
• Batch Record & Record Management
• Issue blank batch records, logbooks, and associated forms to Production prior to scheduled manufacturing runs.
• Review completed batch records for completeness, accuracy, and compliance with cGMP requirements; identify and document discrepancies for QA review.
• Maintain supplier qualification files.
• Review and approve finished good specifications.
• Maintain organized, secure, and retrievable records for all completed batch records, COAs, deviation reports, and related quality documentation.
• Support the timely reconciliation and closure of batch records following production completion.
• Assist in the preparation and compilation of product history files and regulatory submission packages as needed.
• Regulatory Compliance & Audit Readiness
• Ensure all document control activities are conducted in full compliance with 21 CFR Part 111 (cGMP for dietary supplements) and applicable regulatory requirements.
• Maintain the document management system in an audit-ready state at all times; prepare document packages and summaries for internal and external audits or inspections.
• Perform supplier qualification.
• Investigate non-conforming materials and disposition them as appropriate.
• Determine appropriate test methods for finished products and raw materials using compendial methods (USP, AOAC, etc).
• Support GMP audits and regulatory inspections by retrieving requested records, organizing document packages, and responding to documentation-related findings.
• Track and assist in the closure of documentation-related corrective and preventive actions (CAPAs) and audit observations.
• Assist in maintaining compliance with FDA electronic records requirements and data integrity standards where applicable.
• SOP Development & Training Support
• Coordinate the development, review, and approval of new and revised SOPs with department owners and Quality Assurance.
• Maintain SOP review schedules and proactively initiate periodic SOP reviews to ensure documents remain current and accurate.
• Assist in the development and maintenance of training records associated with SOP acknowledgments and controlled document distributions.
• Provide guidance to department personnel on correct document completion practices, change request procedures, and document control requirements.
• Cross-Functional Collaboration
• Work closely with Quality Assurance, Production, R&D, Regulatory, and Operations teams to support document-related needs across the organization.
• Communicate proactively with department managers regarding pending document approvals, overdue reviews, or open change requests.
• Support onboarding processes by ensuring new employees receive current versions of all relevant controlled documents.
• Participate in cross-functional meetings, quality reviews, and continuous improvement initiatives as requested.

QUALIFICATIONS & SKILLS

Associate's or Bachelor's degree in Life Sciences, Food Science, Chemistry, Biology, or a related field preferred (or equivalent experience in a document control or quality assurance role within a regulated manufacturing environment).

• Experience managing controlled documents including SOPs, batch records, forms, specifications, and work instructions in a regulated environment.
• Familiarity with document management systems (DMS) or electronic quality management systems (eQMS); experience with paper-based systems also acceptable.
• Strong attention to detail with the ability to review documents for accuracy, completeness, and regulatory compliance.
• Excellent organizational and recordkeeping skills; demonstrated ability to manage multiple document requests and deadlines simultaneously.
• Strong written and verbal communication skills with the ability to communicate document control requirements clearly across departments.
• Proficient in Microsoft Office Suite (Word, Excel, Outlook); experience with document formatting and version control practices.
• Self-motivated, reliable, and able to work independently with minimal supervision in a fast-paced manufacturing environment.
• Maintain a regular and dependable attendance record with the ability to commit to at least 40 hours weekly during normal business hours of 8:00am
• 5:00pm MST with minimal instances of unplanned absence.
• Minimum 2-4 years of experience in a document control, quality assurance, or regulatory affairs role within a nutraceutical, pharmaceutical, food, or similarly regulated manufacturing environment.
• Working knowledge of cGMP regulations applicable to dietary supplement manufacturing (21 CFR Part 111).
• Experience with electronic document management or quality management platforms (e.g., MasterControl, Veeva, Qualio, or similar).
• Familiarity with FDA dietary supplement GMP inspection processes and audit support activities.
• Experience supporting CAPA processes and tracking documentation-related corrective actions.
• Experience reviewing and issuing batch records in a contract manufacturing environment.

Knowledge of 21 CFR Part 11 electronic records and electronic signatures requirements.

Pay:

From $20.00 per hour Expected hours: 40.0 per week

Benefits:

Dental insurance Health insurance Paid time off Vision insurance Application Question(s): What is your pay expectation for this position?

Work Location:

In person