Document Control Specialist

About the Role

We are an OTC (over-the-counter) drug manufacturing company seeking a detail-oriented Document Control Specialist
to support our Quality and Regulatory operations. This role is responsible for managing controlled documents and reviewing key quality records such as batch records, customer complaints, NCRs, OOS investigations, RCC logs, and validation protocols to ensure compliance with cGMP and company procedures.

Key Responsibilities

• Batch Record Review & Release Support
• Review executed Batch Production Records (BPRs) and Packaging Batch Records for completeness, accuracy, and compliance with SOPs and cGMP.
• Verify all required signatures, entries, calculations, and attachments (COAs, in-process test results, yields, deviations, etc.).
• Identify documentation errors and work with Production, QC, and QA to resolve discrepancies.
• Quality & Compliance Documentation
• Maintain and update controlled documents (SOPs, WI, forms, templates, logs, protocols, reports) in the document control system.
• Ensure current, approved versions of documents are available at points of use and obsolete versions are properly archived.
• Support document change control: routing, tracking, and filing of change requests and approvals.
• Log & Record Review
• Review and maintain:
• Customer Complaint Log
• Nonconformance (NCR) Log
• Out-of-Specification (OOS) Log
• Root Cause / RCC Log
• Deviation and CAPA records (as applicable)
• Check entries for completeness, consistency, and alignment with related investigations and corrective actions.
• Ensure logs are kept up to date and readily retrievable for audits and inspections.
• Validation & Qualification Documentation
• Assist with formatting, issuing, and tracking validation protocols and reports (e.g., equipment, process, cleaning, analytical methods).
• Verify that protocols and reports are complete, signed, and filed according to SOP.
• Maintain validation master list or index to ensure status is clearly documented.
• Audit & Inspection Support
• Prepare and organize documentation for internal audits, customer audits, and regulatory inspections.
• Retrieve requested batch records, logs, SOPs, and validation documents promptly.
• Assist in implementing documentation-related CAPAs and improvements identified during audits.
• General Quality System Support
• Assist in training document users on document control procedures and forms.
• Support continuous improvement of documentation practices and templates.
• Perform other QA documentation tasks as assigned by the Quality/Regulatory leadership.

Qualifications

• Education:
• High school diploma or GED required.
• Associate's or Bachelor's degree in a scientific, technical, or related field preferred.
• Experience:
• 1–3 years of experience in a GMP-regulated environment (OTC, pharmaceutical, medical device, or similar).
• Experience with
  batch record review
  and/or
  document control
  strongly preferred.
• Knowledge & Skills:
• Familiarity with FDA cGMP
  requirements (21 CFR Parts 210/211) for OTC drug manufacturing.
• Experience working with Quality records such as complaints, NCRs, OOS, deviations, CAPA, or validation documentation.
• Strong attention to detail and organizational skills; able to manage multiple logs and document workflows.
• Proficient in MS Office (Word, Excel, Outlook); experience with electronic document management systems is a plus.
• Strong written and verbal communication skills.
• Ability to work collaboratively with Production, QC, QA, and Regulatory teams.

Personal Attributes

• Highly organized and detail-oriented.
• Able to follow procedures precisely and raise questions when something doesn't look right.
• Professional, reliable, and able to maintain confidentiality of quality and regulatory records.

Work Schedule & Compensation

• Schedule: Monday–Friday, 8:00 AM–5:00 PM
• Compensation: $18-20/hr
• Benefits: Medical, dental, vision, PTO