Quality Control Technician II

Join to apply for the Quality Control Technician II role at BioSpace By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge. About the role As a Quality Control Technician II, you will ensure compliance with procedures and regulatory requirements in the manufacturing facility. The incumbent is responsible for quality support and oversight of manufacturing operations, which includes presence on the floor and for 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 in a 2-2-3 work schedule. How You Will Contribute 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. What You Bring To Takeda 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 Important Considerations At Takeda, our patients rely on us to deliver quality products. As a result, we must follow strict rules in our manufacturing facilities to ensure we are not endangering the quality of the product. In this role, you may: 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 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. 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 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 overtime as required We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI. #J-18808-Ljbffr BioSpace