Quality Control Technician II - Visual Inspection; Nights in Round Lake

About the role

As a Quality Control Technician II, your primary responsibility is to ensure compliance with procedures and regulatory requirements in the manufacturing facility. You will provide quality support and oversight of manufacturing operations, including presence on the floor and performing Acceptable Quality Limit (AQL) sampling of finished product. Additional responsibilities include triage for potential issues on the floor, raw material investigations, Quality on the Shop Floor (QOTSF), online batch documentation review, sample management, kitting of batches, and raw materials release.

This role is a night shift, 6:00pm – 6:30am on a 2-2-3 work schedule.

• Perform Acceptable Quality Limit (AQL) sampling of finished product. Identify and assess quality risk in production operations daily.
• Execute Quality on the Shop Floor (QOTSF) and review checklists. Programs are part of manufacturing support and compliance enforcement.
• Initiate JDE work orders for inventory management and preventive maintenance to address issues in a timely manner.
• Perform sample management (sterility, stability, etc.) for appropriate facilities and ensure proper storage and disposal of retention samples. Perform triage with manufacturing, engineering, and maintenance to resolve potential issues on the floor and escalate as needed.
• Demonstrate solid interpersonal skills and strong attention to detail.
• Collaborate as a team player with good problem-solving and verbal and written communication skills.
• Facilitate kitting operations for packaging — issue and return of preprinted materials physically and electronically.
• Manage movement of materials/products physically and electronically for quarantine and reject areas.
• Review batch documentation, perform documentation review and approval, and consult with manufacturing to address any required corrections.
• Serve as Subject Matter Expert (SME) and provide training to other employees as required.
• Maintain data integrity and ensure compliance with company SOPs, FDA regulations, and cGMP.
• Monitor product quality through required visual testing follow-ups.
• Contribute to a collaborative team environment within quality operations and other work teams to increase efficiency, solve problems, generate cost savings, improve quality, and support new products.
• Support regulatory audits as required.

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

• Work in a controlled environment requiring gowning and protective clothing; may include hearing protection in loud areas.
• Remove makeup, jewelry, contact lenses, nail polish, and artificial fingernails in the manufacturing environment.
• Work in a cold, wet environment; combination of sedentary work and movement around the facility.
• Must be able to lift, push, pull, and carry up to 50 lbs without equipment and be able to stand/walk for extended periods on an 8–12 hour shift.
• May require bending, twisting, reaching overhead, and/or squatting motions; repetitive motions with hands and wrists.
• Vision requirement: 20/20 near and distance with or without corrective lenses; color vision may be required for visual inspection roles.
• Indoor working conditions and exposure to moving equipment and machinery.
• Compliance with gowning requirements; no makeup, jewelry, nail polish, or artificial nails in the manufacturing environment.
• Some clean room and/or controlled storage conditions.
• May be exposed to cephalosporin and must not be allergic.
• Must be able to work non-traditional hours, including weekends and holidays, and be able to work a 12-hour shift (6:00am – 6:30pm or 6:00pm – 6:30am) on a 2-2-3 rotation to support a 24/7 operation.
• Must be able to work overtime as required and communicate in English (read, write, and follow detailed instructions).