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. What This Role Does Day-to-Day 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 elevate 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 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, PPE, and quality system requirements. Support continuous improvement by identifying recurring issues, communicating improvement opportunities, and participating in process or quality system improvements. 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. Maintains objectivity, professionalism, and confidentiality when supporting investigations, CAPAs, complaints, or quality events. 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 broader quality systems and pharmaceutical manufacturing processes. Shows motivation to grow within Quality Assurance and take on additional QMS, investigation, documentation, or floor support responsibilities over time. Required Qualifications 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. Maintains objectivity, professionalism, and confidentiality when supporting investigations, CAPAs, complaints, or quality events. 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 broader quality systems and pharmaceutical manufacturing processes. Shows motivation to grow within Quality Assurance and take on additional QMS, investigation, documentation, or floor support responsibilities over time. Physical Requirements 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 pounds at times. Ability to work in office, manufacturing, warehouse, receiving, controlled, or quality support areas as needed. Ability to wear required PPE and follow safety, cleanliness, gowning, and facility requirements. Ability to review documentation, labels, product information, and computer‑based records for extended periods. Work Environment This role supports Quality Assurance activities in a 503B pharmaceutical manufacturing environment. Work may take place in office, production, warehouse, receiving, controlled, or other quality support areas. Employees are expected to follow cGMP, GDP, PPE, safety, documentation, cleanliness, and conduct expectations at all times. The role may involve working near production materials, finished products, labels, packaging components, equipment, or manufacturing documentation that must be handled according to approved procedures. This is a quality‑focused role where accuracy, consistency, escalation, and documentation matter. The QA Technician I ensures that issues are identified early, records are complete and accurate, and operational teams have the QA support needed to maintain compliant manufacturing and product quality. Benefits We offer a comprehensive and competitive benefits package designed to support the health, well‑being, and financial security of our employees and their families. Medical, dental, and vision insurance options Employer‑paid life insurance and disability coverage Employee Assistance Program 401(k) retirement plan with employer match Paid time off (PTO), sick leave 7 paid holidays Opportunities for professional growth in a regulated pharmaceutical manufacturing environment Employee‑focused culture emphasizing safety, quality, and teamwork The application window for this position is anticipated to be open at least 25 days. #J-18808-Ljbffr