Quality Operations, Analyst II, Floor Support
Takeda
Summary
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.
Job description
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 TrackWise, 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.
Requirements
- 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 TrackWise, 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.
Benefits
- 401(k) Matching
- Medical, Dental & Vision
- Paid Time Off
Company overview
Takeda Pharmaceutical Company Limited is a Japanese multinational pharmaceutical company founded in 1781 and incorporated in 1925. As one of the world's top 20 largest pharmaceutical companies by revenue and the third largest in Asia, Takeda specializes in developing and commercializing innovative medicines across several therapeutic areas including oncology, rare diseases, neuroscience, gastroenterology, plasma-derived therapies, and vaccines. With approximately 49,095 employees globally, the company operates research and development centers, manufacturing facilities, and commercial operations across 39 U.S. states and numerous countries worldwide. Takeda maintains dual headquarters in Tokyo and Osaka, Japan, with significant operations in Cambridge, Massachusetts, where it serves as the largest life sciences employer in the state. The company's patient-focused approach is guided by its Takeda-ism values of Integrity, Fairness, Honesty, and Perseverance, emphasizing a commitment to delivering life-transforming treatments while advancing sustainable healthcare solutions. Takeda's extensive portfolio includes both innovative biologics and small molecule drugs, supported by strategic acquisitions and partnerships that have expanded its capabilities in areas such as immuno-oncology and rare disease treatments.