Quality Support Technician

Description

The Quality Support Technician supports daily Quality operations, with a primary focus on production line clearances and readiness checks. Additional responsibilities include label issuance and reconciliation, raw material sampling, and controlled document and record management. This role works closely with Production, Warehouse, and Quality personnel to support accurate documentation, traceability, and compliance with approved procedures, current Good Manufacturing Practices (cGMP), and applicable 21 CFR Part 111 requirements.

Responsibilities:

• Perform and document production line clearances and readiness checks using approved procedures and checklists.

• Verify that materials and labels have the required approved status before use in production; report discrepancies to Quality leadership.

• Issue, control, and reconcile labels in accordance with approved procedures, maintaining accurate issuance and reconciliation records.

• Collect, identify, and document raw material samples in accordance with approved sampling procedures and handling requirements.

• Scan, index, archive, and retrieve completed production and Quality records while maintaining document integrity and traceability.

• Maintain accurate and current Quality logs, including label, material, sampling, and clearance records, as assigned.

• Follow Good Documentation Practices (GDP) and promptly report documentation errors, discrepancies, and potential quality concerns to Quality leadership.

• Retrieve and organize records for audits, internal reviews, and other authorized requests, as required.

• Communicate the status of clearances, sampling, labels, and documentation with Production, Warehouse, and Quality personnel.

• Perform additional Quality support and documentation duties as assigned.

Requirements

• High school diploma or equivalent required; associate degree preferred.
• Previous experience in Quality or manufacturing preferred, but not required.
• Basic understanding of cGMP and GDP principles preferred; training will be provided.
• Familiarity with 21 CFR Part 111 preferred, but not required.
• Strong attention to detail and the ability to follow written procedures and accurately document activities.
• Strong organizational and time management skills, with the ability to prioritize assignments and maintain accuracy when managing multiple tasks.
• Proficiency with Microsoft Office and the ability to learn electronic document and recordkeeping systems.
• Clear communication skills and the ability to work effectively with Production, Warehouse, and Quality teams.
• Ability to work independently after training, recognize the limits of assigned authority, and seek guidance when needed.
• Willingness to learn and develop skills in a regulated manufacturing environment.