Quality Control Technician II

Role Summary

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

Responsibilities

• Performs Acceptable Quality Limit (AQL) sampling of finished product; identifies and assesses quality risk in production operations daily.
• Executes Total Integrated Quality (TIQ) / Quality on the Shop Floor (QOTSF) and reviews checklists as part of manufacturing support and compliance enforcement.
• Initiates JDE work orders for inventory management and preventive maintenance to address issues promptly.
• Performs sample management (sterility, stability, etc.) and manages retention samples; handles sampling of raw materials in an ISO Classified environment and coordinates testing shipments to laboratories.
• Initiates investigations for failures related to processes or raw materials out of specification.
• Triages with manufacturing, engineering, and maintenance to resolve on-floor issues and escalates as needed.
• Facilitates packaging kitting operations, including issuing and returning preprinted materials physically and electronically.
• Manages movement of materials and products for quarantine and reject areas.
• Reviews batch record documentation, approves batch documentation, and collaborates with manufacturing to address corrections.
• Acts as Subject Matter Expert (SME) and provides training to other employees as required.
• Maintains data integrity and ensures compliance with SOPs, specifications, FDA, and cGMP regulations.
• Monitors product quality through required visual testing follow-ups.
• Contributes to a team environment within quality operations and other work teams to improve efficiency, solve problems, and support new product development.
• Supports regulatory audits as required.

Qualifications

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

Skills

• Quality assurance and regulatory compliance awareness
• Documentation and data integrity
• Operational troubleshooting and collaboration across cross-functional teams
• Visual inspection and laboratory specimen handling

Education

• High School Diploma or GED with 2+ years of related work experience or Associates degree or higher with 1+ years related work experience.

Additional Requirements

• Work in a controlled environment requiring gowning and protective clothing; potential hearing protection in loud areas.
• Must remove makeup, jewelry, contact lenses, nail polish, and artificial nails in the manufacturing environment.
• Work in cold, wet environments and around chemicals requiring respiratory protection.
• Combination of sedentary work and walking; ability to carry up to 10 lbs, lift up to 10 lbs, and push/pull up to 20 lbs with assistance.
• Must stand/walk for extended periods during 8–12 hour shifts; may involve bending, twisting, reaching overhead, and squatting motions.
• Indoor working conditions; may work around moving equipment and machinery; gowning and safety gear required; no makeup, jewelry, nail polish, or artificial nails in manufacturing areas.
• Clean Room and/or storage condition exposure; potential allergy to cephalosporin.
• 21/20 vision requirements for visual inspection tasks; must not be colorblind for applicable roles.
• Ability to work non-traditional hours, including weekends and holidays; overtime as required.