Quality Support Technician

Description

The Quality Technician (Support & Document Control) supports the Quality Department by assisting with day-to-day quality operations, production support activities, and the management of controlled documentation in accordance with established procedures, current Good Manufacturing Practices (cGMP), and 21 CFR Part 111. This role focuses on production clearances, label issuance, raw material sampling, and document control activities, including batch record management, log maintenance, and record archiving.

The position is well-suited for a detail‑oriented individual who plays a key support role in maintaining compliance, traceability, and production readiness within a regulated manufacturing environment.

• Support the Quality Technicians with production clearances and line readiness activities.
• Issue, control, and reconcile labels in accordance with approved procedures.
• Perform raw material sampling following established SOPs.
• Verify material and label status prior to release for production.
• Print, assemble, and issue Master Batch Records (MBRs) for production runs.
• Scan, index, and archive completed MBRs and production documentation.
• Maintain and update quality and production logs (MBRs, labels, materials, etc.).
• Ensure controlled documents are current, accurate, and properly stored.
• Retrieve quality records for audits, reviews, and internal requests.
• Support document revisions by distributing updated documents and removing obsolete versions.
• Follow Good Documentation Practices (GDP) at all times.
• Identify documentation errors or discrepancies and elevate to Quality leadership.
• Communicate effectively with Production, Warehouse, and Quality teams.
• Support the implementation and maintenance of quality systems, regulatory programs, and certification requirements across the facility.
• Support the Quality team with additional quality and documentation tasks as assigned.

• High school diploma or equivalent required;
  Associate degree preferred.
• Prior experience in Quality, Manufacturing, or Document Control preferred.
• Basic understanding of cGMP principles (training will be provided).
• Familiarity with 21 CFR Part 111 is preferred but not required.
• Strong attention to detail and ability to follow written procedures.
• Strong organizational and time‑management skills, with the ability to prioritize effectively.
• Computer literacy; proficient in Microsoft Office Suite and comfortable working within digital record‑keeping systems.
• Ability to manage multiple tasks simultaneously while maintaining accuracy and compliance.
• Capable of working both independently and collaboratively within a team environment.
• Demonstrates a strong willingness to learn and grow within a regulated manufacturing setting.