Quality Control Technician II

Role Summary

Quality Control Technician II is responsible for ensuring compliance with procedures and regulatory requirements in the manufacturing facility. The role provides quality support and oversight of manufacturing operations, including floor presence, performing AQL sampling of finished product, triage for potential issues, raw material investigations, QOTSF, online batch documentation review, sample management, batch kitting, and raw materials release. This is a night shift role on a 2-2-3 schedule (6:00 PM – 6:30 AM).

Responsibilities

• Performs Acceptable Quality Limit (AQL) sampling of finished product and identifies quality risk in production operations daily.
• Executes Total Integrated Quality (TIQ)/Quality on the Shop Floor (QOTSF) and reviews checklists; programs support manufacturing and compliance enforcement.
• Initiates JDE work orders to address issues in a timely manner.
• Performs sample management (sterility, stability, etc.) and ensures proper storage/disposal of retention samples; handles raw materials sampling in ISO environments and shipments to laboratories.
• Initiates investigations for failures related to processes or raw materials out of specification.
• Performs triage with manufacturing, engineering, and maintenance to resolve floor issues and escalate as needed.
• Facilitates kitting operations for packaging (issue and return of preprinted materials physically and electronically).
• Manages movement of materials/products for quarantine and reject areas.
• Reviews batch documentation and contributes to batch documentation corrections in collaboration with manufacturing.
• Acts as Subject Matter Expert (SME) and provides training to other employees as required.
• Maintains data integrity and ensures compliance with SOPs, FDA, and cGMP regulations.
• Monitors product quality through required visual testing follow ups.
• Contributes to a team environment within quality operations and with other teams to increase efficiency, solve problems, generate cost savings, improve quality, and support new products.
• Supports regulatory audits as required.

Qualifications

• High School Diploma or GED with 2+ years of related work experience or Associate’s degree or higher with 1+ years of related work experience.
• Solid interpersonal skills and high attention to detail.
• Team player with strong problem-solving, verbal, and written communication skills.
• Knowledge of Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP).
• Proficient in Microsoft Word, Excel, Outlook, and SharePoint.
• Ability to work with JDE, EBM, TW workflows, Systech and other Learning Management and Document Management systems.

Skills

• Quality assurance and regulatory compliance in manufacturing
• Documentation control and batch record review
• Laboratory sample management and handling
• Troubleshooting and cross-functional collaboration
• Data integrity and adherence to SOPs

Education

• High School Diploma or GED; Associate’s degree or higher preferred if applicable

Additional Requirements

• Work in controlled environments with gowning and protective clothing; may require hearing protection in loud areas.
• Personal grooming standards in manufacturing environments (no cosmetics, jewelry, or artificial nails as specified).
• Cold, wet environments; exposure to chemicals requiring respiratory protection may occur.
• Combination of sedentary work and walking; ability to carry up to 10 lbs, lift up to 10 lbs, push/pull up to 20 lbs with equipment.
• Stand/walk for extended periods during an 8–12 hour shift; may involve bending, twisting, reaching, and squatting.
• Indoor working conditions; may work around moving equipment and machinery; may require extended non-traditional hours including weekends/holidays; overtime as required.
• Vision requirements for visual inspection tasks (20/20 applicable with or without glasses/contacts); color vision requirements may apply for visual inspection roles.
• May be exposed to cephalosporins and must not be allergic.