Quality Assurance Technician

Quality Assurance Technician I

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 finished goods and inspection, labeling coordination, GMP document review, 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 inspecting in-process and finished products, verifying label or component information, reviewing room and equipment logs, entering quality data, label inventory audits.

The QA Technician I may also support investigations, CAPAs, effectiveness checks, receiving inspection support. 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.

Key responsibilities include:

• Perform 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 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, or inspection requirements as assigned.
• Assist with investigations related to deviations, documentation discrepancies, process concerns, product issues, label discrepancies, complaints, or other quality events.
• Identify and escalate 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, PPE, and quality system requirements.
• Support continuous improvement by identifying recurring issues, communicating improvement opportunities.
• Perform other duties as assigned based on business and quality needs.

What success looks like:

• Understands that QA support directly impacts patient safety, product quality, product release, and regulatory compliance.
• Reviews documentation carefully and catches missing, inconsistent, incomplete, or inaccurate information before it creates a larger issue.
• Identifies product, material, label, documentation, or process concerns and escalates appropriately instead of making assumptions or unsupported decisions.
• Communicates clearly with Production, Warehouse, Receiving, QC, QA, and leadership, especially when priorities shift or concerns need follow-up.
• Stays organized while managing multiple tasks, open items, deadlines, and documentation requirements.
• Follows SOPs and work instructions exactly and understands the importance of cGMP, GDP, and data integrity.
• Demonstrates accountability, curiosity, and willingness to learn pharmaceutical manufacturing processes.
• Shows motivation to grow within Quality Assurance and take on additional documentation and/or floor support responsibilities over time.

Physical requirements include:

• Ability to sit, stand, walk, bend, reach, or perform computer-based work for extended periods as required by business needs.
• Ability to lift up to 50-75 pounds at times.
• Ability to work in office, manufacturing, warehouse, receiving, controlled, or…