Quality Operations, Analyst II, Floor

Join Takeda as a Quality Operations, Analyst II, Floor Support, you handle problems of limited scope and complexity, adhering to established policies and procedures. Your decision-making is within a defined scope, using standardized methods to analyze situations and data. You are developing knowledge of basic principles, theories, and concepts, and beginning to apply industry practices and standards. Typically, this role requires some relevant experience, with contributions mostly related to task-specific activities.

Your primary contacts are with your immediate team, and you work under moderate direction and close supervision, following specific, detailed instructions.

About the role:

The Quality Operations, Analyst II, Floor Support supports quality activities in a biotechnology manufacturing environment by providing quality oversight of good manufacturing practice operations to help ensure compliance, product quality, and patient safety. In this individual-contributor role, you will report to the QA Operations Manager and work closely with Manufacturing, Facilities, Engineering, Quality Control, Regulatory Affairs, and Quality Systems teams to help maintain inspection readiness and support the release of high-quality products.

How you will contribute:

• Provide routine quality oversight and real-time support of good manufacturing practice manufacturing operations
• Perform manufacturing area walkthroughs and compliance assessments to help ensure adherence to good manufacturing practice requirements, standard operating procedures, and regulatory expectations
• Review, Issue, and/or approve documents such as batch records, logbooks, protocols, reports, and supporting quality records
• Support cross-functional teams in resolving quality and compliance concerns
• Monitor quality metrics and trend data to identify compliance risks and support continuous improvement
• Support deviations, corrective and preventive actions, change controls, internal audits, customer audits, and regulatory inspections as needed
• Help maintain a state of continuous inspection readiness
• Provide quality guidance and compliance coaching to manufacturing personnel and site partners
• Improve documentation quality and Right First-Time performance
• Contribute to a culture of quality, accountability, and continuous improvement

What you bring to Takeda:

• Bachelor’s degree or higher with 4+ years of relevant industry experience in life sciences, engineering, chemistry, microbiology, biotechnology, or a related field preferred.
• At least 3 years of experience in Quality Assurance, manufacturing, Quality Control, validation, or a related good manufacturing practice-regulated field
• Knowledge of good manufacturing practice, good documentation practices, data integrity, quality systems, and quality risk management
• Ability to review documentation and resolve quality issues
• Experience with Track Wise, SAP, laboratory information management systems, electronic document management systems, or Veeva preferred
• Experience supporting regulatory inspections and internal audits preferred Training in Lean, Six Sigma, or American Society for Quality methods preferred
• 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.
• Ability to work independently while contributing effectively in a multidisciplinary team environment.

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:

• 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…