Quality Control Technician II - Visual Inspection

Role Summary

As a Quality Control Technician II, you will ensure compliance with procedures and regulatory requirements in the manufacturing facility, providing quality support and floor oversight. You will perform Acceptable Quality Limit (AQL) sampling of finished product and participate in 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 (6:00 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 Quality on the Shop Floor (QOTSF) and reviews checklists. Programs are part of manufacturing support and compliance enforcement.
• Initiation of JDE (inventory management system and preventive maintenance system) work orders if required to address issues in a timely manner.
• Performs sample management (Sterility, stability, etc.) to appropriate facilities and is responsible for the appropriate storage and disposal of retention samples. Performs triage with manufacturing, engineering, and maintenance to resolve potential issues on the floor and escalate if needed.
• Solid interpersonal skills and great attention to detail.
• Team player with good problem-solving and good 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 learn and work with JDE, EBM, TW workflows, Systech, and other Learning Management and Document Management systems.
• Facilitates kitting operations for packaging – issue and return of preprinted materials physically and electronically.
• Handles movement of materials/products physically and electronically for quarantine and reject areas.
• Review Lead Manufacturing support activities, including batch record documentation review. Perform review and approval of batch documentation and consult with manufacturing to address any required corrections.
• Subject Matter Expert (SME) and provides training to other employees as required.
• Maintain data integrity and ensure compliance with company SOPs and specifications, FDA, and cGMP regulations.
• Monitor product quality through the performance of required visual testing follow-ups.
• Actively contributes to a team setting within quality operations and potentially with other work teams to increase efficiency, solve problems, generate cost savings, improve quality, and provide new product support.
• Support regulatory audits as required.

Qualifications

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

Skills

• Proficient in Microsoft Word, Excel, Outlook, and SharePoint.

Additional Requirements

• In general, the position requires a combination of sedentary work and walking around, observing the conditions of the facility.
• Must be able to lift, push, pull, and carry up to 50 lbs without material handling equipment, and push or pull pallets of material with material handling equipment. Must be able to stand and/or walk for an extended period over an 8–12-hour shift between rooms and across the site.
• May require bending, twisting, reaching overhead, and/or squatting motions to perform certain tasks.
• Repetitive motions with hands, wrists, turning head, bending at knees, and waist.
• 20/20 near and distance vision (Applies to roles performing visual inspection only) with or without glasses and/or contacts.
• May not be colorblind (Applies to roles performing visual inspection only).
• Indoor working conditions.
• Will work around moving equipment and machinery.
• May be required to work in controlled environments requiring special safety gear or gowning; will be required to follow gowning requirements and wear protective clothing over the head, face, hands, feet, and body. No make-up, jewelry, nail polish, or artificial fingernails may be worn in the manufacturing environment.
• Some Clean Room and/or cool/hot storage conditions.
• May be exposed to cephalosporin and must not be allergic to it.
• Must be able to work non-traditional work hours, including weekends and holidays, as needed.
• Must be able to work a 12-hour shift (6:00 am – 6:30 pm or 6:00 pm – 6:30 am), in a 2-2-3 rotation, including weekends and holidays, to support a 24/7 operation.
• Must be able to work overtime as required.
• Must be able to speak, read, write, and follow detailed written and oral instructions in English.