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Senior Quality Assurance Specialist
2 months ago
We are seeking a highly skilled Senior Quality Analyst to join our team at Takeda Pharmaceutical. As a Senior Quality Analyst, you will be responsible for ensuring the quality of our products and processes, and for identifying and mitigating potential quality risks.
Key Responsibilities- Perform quality assurance activities for Teardown, Fractionation, and Purification, observing cGMP, GDDP, FDA, and Regulatory Standards, ISO requirements, and internal standard operating procedures.
- Provide daily Quality on the Shop Floor oversight to manufacturing batch record and documentation review for accuracy and compliance to procedure.
- Participate in troubleshooting and problem-solving of manufacturing issues and support daily Return to Operation assessment and Change Control process.
- Assure compliance with cGMP, GDDP, and company procedures internal and external audits.
- Identify potential Quality and compliance risk in activities and processes according to procedural requirements, Takeda Quality Standards.
- High school diploma or GED. 6+ years of experience or AA or higher with 4+ years related work experience.
- Knowledge of Regulations, Application of Good Data and Documentation Practices (GDDP) and application of current Good Manufacturing Practices (cGMP).
- General knowledge of biopharmaceutical / biotech manufacturing industry and systems.
- Good investigational experience.
- Have good critical thinking and problem-solving skills (DMAIC and Lean).
- Perform and analyze trending using DeltaV system and EBM.
- Support department / plant goals.
- Approve investigations as assigned.
- Yellow Belt/ Green Belt training or certification.
We offer a competitive salary and benefits package, including medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits.
We are an equal opportunity employer and welcome applications from diverse candidates. We are committed to creating a diverse and inclusive workplace that reflects the communities we serve.
