Document Control Specialist

JOB OVERVIEW

We are seeking a detail-oriented and highly organized Document Control Specialist to join our dynamic team. The Document Control Specialist administers the controlled document system for AmeriPouch's Quality Management System and performs batch record issuance, review, and release activities in support of Quality Assurance. The role ensures that controlled documents are accurate, current, properly approved, and available to all users, and that batch production records are issued, reconciled, reviewed, and dispositioned for release in compliance with cGMP requirements. This position supports the full oral-pouch production process — raw material receipt, powder blending, pouch filling, finished good puck production, and labeling — and reports to the Quality Assurance Manager.

RESPONSIBILITIES

Document Control

• Administer the controlled document lifecycle, including document numbering per AP-SOP, AP-POL, AP-FRM, AP-REC, AP-VAL, AP-LTR, and AP-MEM conventions, revision control, and change history.
• Route controlled documents for review and approval and track signature completion to release.
• Perform controlled distribution of current documents and retrieval of obsolete and superseded copies.
• Maintain the master document index and ensure it reflects current document status.
• Support periodic review scheduling and notify document owners of upcoming reviews.
• Manage records retention and archival in accordance with the records retention policy.
• Maintain Batch Production Record (BPR) lifecycle documentation across all five production stages: raw material receipt, powder blending, pouch filling, finished good puck production, and labeling.

Batch Record Issuance, Review and Release

• Issue Batch Production Records to production and reconcile issued records upon return to ensure completeness and accountability.
• Review raw material receipt documentation for completeness and accuracy prior to production.
• Review executed pouch filling and finished good puck production records against procedures and specifications.
• Verify label issuance and reconciliation records for the labeling stage.
• Coordinate with Quality Control on testing status and results required for batch disposition.
• Disposition executed batch records for release in Wherefour based on completeness and QC review status, and schedule lot release accordingly.

Quality Systems Support

• Administer training record documentation associated with controlled document releases and revisions.
• Support deviation, nonconformance, and change-control documentation and recordkeeping.
• Support digitization of batch records and controlled documents, including data migration and system administration readiness for electronic batch record platforms.
• Maintain organized, audit-ready document control and batch record files.

KNOWLEDGE AND SKILL

• Working knowledge of FDA, GMP, SQF and ISO requirements applicable to dietary supplement and tobacco/nicotine oral pouch manufacturing.
• Familiarity with cGMP documentation practices, Good Documentation Practices (GDP), and controlled record management.
• Ability to interpret specifications, procedures, and quality records and to apply them consistently.
• Ability to relate and work well with people across all functions.
• Excellent organizational skills.
• Excellent verbal and written communication skills.
• Attention to detail.
• Ability to multi-task and work well under pressure.

SUCCESSFUL CANDIDATES

• Must have effective communication and interpersonal skills across all functions within the organization and outside.
• Strong organizational and record keeping skills are required.
• Strong working knowledge of Word, Excel, and PowerPoint is necessary.
• Requires the ability to check mathematical calculations.

QUALIFICATIONS

• High school diploma or equivalent required; associate or bachelor's degree in a science, quality, or related discipline preferred.
• Prior experience in a regulated manufacturing quality function (dietary supplement, pharmaceutical, food, or tobacco/nicotine) preferred.
• Experience working within an electronic ERP/MES or quality management system preferred.

Pay: $22.00 - $26.00 per hour

Benefits:

• Dental insurance
• Health insurance
• Paid time off

Work Location: In person

Salary : $22 - $26