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Job Description

About the role:

The primary responsibility is working on Materials release and approval of completed documentation for batch folders following GMP/GDP. You will be accountable for Quality oversight on the floor and responsible for trending of observations from floor to improve them. You will be accountable for manufacture support activities on the floor, revising SOPs and forms, and developing training. This position is a second shift role Monday - Friday from 4:00 PM - Midnight.

How you will contribute:

• Responsible for raw material and bulk container receipts, release, and investigation if any issues found. Follow-up with appropriate Takeda facilities for documentation correction in.
• Manufacturing support activities including batch record documentation, issuance of Batch record, approval of OSI PI Reports, scanner card delivery of test and stability samples, label copy control and issuance, raw material release, in-process work order release, and retain sample management.
• Responsible for oversight of quality line operations concerning product quality and conformance to regulations and Takeda quality procedures.
• Quality Approval of labeling artwork and specifications for packaging material using appropriate artwork management software.
• Identify and assess quality risk in production operations daily. TIQ/QOTSF review of checklists and trending of observations for monthly quality council. Responsible for TIQ/QOTSF program management.
• Develop training materials and procedures and participation on cross-functional teams to implement process improvements. Be a Subject Matter Expert (SME) and provide training to employees needed on relevant areas.
• Demonstrate effectiveness in task completion and empowerment of others, deviation/nonconformance management, training, and problem solving
• Complete interfacility impact assessments for product/process changes.
• Manage root cause investigations, close deviations, assignment of proper corrective actions, and facilitate implementation for Manufacturing under the direction of Compliance Management.
• Participate in internal and external regulatory audits as a SME for Quality operations and present to auditor.

What you bring to Takeda:

• Typically requires, bachelors' degree in science, engineering, or other related technical field. Some related experience.
• Knowledge of the local and international regulatory environment and regulations for manufacture of biological products.
• Analytical and problem-solving skills.
• Acts as a change agent to sufficiently motivate team members to achieve team goals.
• You must not be allergic to Cephalosporin drugs.
• Ability to walk 1-3 miles and lift 10 lbs. during a workday is required.
• Indoor working conditions

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. You may:

• May wear personal protective equipment (PPE) and other clean room garments daily. This may include safety shoes, safety glasses, aprons, face shields, lab coats, full body gowns, hair nets and gloves and hearing protection.
• Need to remove all make-up, jewelry, contact lenses, nail polish and 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.