Quality Assurance Technician

Position Summary:

The Quality Assurance Technician I supports Quality Assurance operations within a 503B pharmaceutical manufacturing environment by helping ensure products, processes, documentation, materials, and labeling activities meet cGMP, company procedure, and quality system expectations. This role provides day‑to‑day QA support across Production, Warehouse, Receiving, and Quality while helping protect patient safety through accurate inspection, documentation, escalation, and follow‑up.

This position is a strong fit for someone who is detail‑oriented, organized, comfortable working in a regulated manufacturing environment, and motivated to grow within pharmaceutical Quality Assurance. The QA Technician I may support a mix of floor‑based quality checks and documentation‑based activities, including sampling and inspection, labeling coordination, GMP document review, QMS support, training/document control support, and follow‑up on quality events or process concerns.

In this role, the QA Technician I helps verify that work performed in manufacturing and support areas is completed accurately, consistently, and in accordance with approved procedures. Daily activities may include sampling or inspecting in‑process and finished products, verifying label or component information, reviewing room and equipment logs, reviewing master batch production records or related GMP documentation, entering quality data, supporting metric and trend tracking, and assisting with quality system records.

The QA Technician I may also support investigations, CAPAs, effectiveness checks, customer complaint follow‑up, supplier‑related activities, receiving inspection support, and document control or training program activities. The role requires the ability to recognize when something does not match the procedure, documentation, label, material, product, or expected process, and to escalate the concern before moving forward.

Because this position supports multiple departments, the ideal candidate must be comfortable communicating with Production, Warehouse, Receiving, Quality Control, Quality Assurance, and leadership. Success in this role requires strong attention to detail, sound judgment, professionalism, follow‑through, and the ability to balance urgency with compliance in a fast‑paced manufacturing environment.

• Perform sampling and inspection of in‑process and finished pharmaceutical products according to approved procedures, specifications, and quality expectations.
• Support and facilitate finished product labeling activities, including label coordination, verification, reconciliation support, documentation, and escalation of labeling discrepancies as assigned.
• Review GMP documentation, including master batch production records, room logs, equipment logs, inspection records, forms, checklists, and other quality‑related documents for accuracy, completeness, and compliance.
• Support manufacturing and receiving activities by verifying materials, components, documentation, supplier‑related information, or inspection requirements as assigned.
• Assist with investigations related to deviations, documentation discrepancies, process concerns, product issues, supplier concerns, label discrepancies, complaints, or other quality events.
• Support corrective and preventive action activities, including fact gathering, follow‑up, implementation support, and effectiveness checks.
• Support quality management system activities, including document control, training program management, record review, quality data entry, metrics, and trending.
• Identify and elevate potential deviations, documentation errors, missing information, product defects, material concerns, label mismatches, or process issues to the appropriate Quality or operational leader.
• Work cross‑functionally with Production, Warehouse, Receiving, QC, QA, and leadership to support compliant operations, timely issue resolution, and product quality.
• Maintain accurate, timely, legible, complete, and attributable documentation in accordance with GDP expectations.
• Follow all applicable cGMP, GDP, FDA, OSHA, DEA, company procedure, safety,…