Quality Control Technician II

Role Summary

Quality Control Technician II responsible for ensuring compliance with procedures and regulatory requirements in the manufacturing facility. Provides quality support and oversight of manufacturing operations, including on-floor activities and performing Acceptable Quality Limit (AQL) sampling of finished product. Performs triage for on-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 follows a day shift (6:00am–6:30pm) on a 2-2-3 schedule.

Responsibilities

• Performs Acceptable Quality Limit (AQL) sampling of finished product. Identifies and assess quality risk in production operations daily.
• Executes Total Integrated Quality (TIQ)/Quality on the Shop Floor (QOTSF) and review of 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 timely manner.
• Performs sample management (Sterility, stability, etc.) to appropriate facilities and responsible for appropriate storage and disposal of retention samples. Samples Raw Materials in an ISO Classified environment, including preparation and shipment of samples to the required laboratories.
• Initiates investigations in the event of a failure pertaining to processes or Raw Material that is deemed to be out of specification.
• Performs triage with manufacturing, engineering, and maintenance to resolve potential issues on the floor and escalate if needed.
• 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 contribute 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 Associates 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).
• 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.

Skills

• Strong attention to detail and a quality-focused mindset.
• Excellent interpersonal and teamwork abilities; solid verbal and written communication.
• Experience with regulatory compliance and documentation practices in manufacturing.
• Proficiency with Microsoft Word, Excel, Outlook, and SharePoint; familiarity with JDE, EBM, TW workflows, Systech, and LMS/DMS systems.
• Ability to act as a Subject Matter Expert (SME) and provide training to others.

Education

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

Additional Requirements

• Work in a controlled environment requiring special gowning and wear protective clothing over the head, face, hands, feet and body. This may include additional hearing protection for loud areas.
• Need to remove all make-up, jewelry, contact lenses, nail polish and/or artificial fingernails while in the manufacturing environment.
• Work in a cold, wet environment.
• Work multiple shifts, including weekends, or be asked to work supplemental hours, as necessary.
• Work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.
• In general, the position requires a combination of sedentary work and walking around observing conditions of the facility.
• Must be able to carry up to 10lbs, lift up to 10lbs, push/pull up to 20lbs (with assistance of 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.
• Indoor working conditions.
• Will work around moving equipment and machinery.
• Some Clean Room and/or cool/hot storage conditions.
• May be exposed to and must not be allergic to cephalosporin.
• 20/20 near and distance vision (applies to roles performing visual inspection only) with or without glasses and/or contacts.
• Must not be colorblind (applies to roles performing visual inspection only).
• Must be able to work non-traditional work hours, including weekends and holidays, as needed.
• Must be able to work a 12-hour shift (6:00am – 6:30pm or 6:00pm – 6:30am), in a 2-2-3 rotation, including weekends and holidays, to support a 24/7 operation.
• Must be able to work overtime as required.