Quality Control Technician II

About the role

Quality Control Technician II is focused on ensuring the quality of processes and product outputs. This includes defining and specifying activities, processes, and standards to meet quality requirements, auditing and monitoring processes, and ensuring product integrity. This role contributes to Takeda's mission by maintaining high standards of quality and compliance.

How you will contribute

• 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.
• Initiation of JDE 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.
• 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.

What you bring to Takeda

• HS Diploma or GED with 2+ years, Associate’s degree or higher with 1+ years of relevant industry experience
• 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.
• Ability to work independently while contributing effectively in a multidisciplinary team environment.

Important Considerations

• 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.
• 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. Some Clean Room and/or cool/hot storage conditions.
• Work multiple shifts, including weekends, or be asked to work supplemental hours, as necessary. The shift is 6:00pm-6:30am, 2-2-3.
• Work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.
• May be exposed to and must not be allergic to cephalosporin.