

New · posted Oct 16
Takeda · Biotechnology
Quality Operations, Analyst II, Floor Support
- Alewife, MA
- On-site
- Full-time
- Associate & Specialist
Open until filled
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
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.
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 contacts.
• May not be colorblind (Applies to roles performing visual inspection only).
• Indoor working conditions.
• Will work around moving equipment and machinery.
• 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. Some Clean Room and/or cool/hot storage conditions.
• Work multiple shifts, including weekends, or be asked to work supplemental hours, as necessary. The shift is 2pm-12:30am.
• Work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.
More about us
At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.
Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.
What you need
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.
Pay
$71,800 – $112,860 a year
Employer providedTakeda Compensation and Benefits Summary
We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.
U.S. Base Salary Range
$71,800.00 - $112,860.00
The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.
For information about our benefits, please click here.
Where you'll work
Alewife, MAOn-siteOpen in Maps (opens in a new tab)
More jobs in Alewife, MAWorking conditions
Worker Type
Employee
Worker Sub-Type
Regular
Time Type
Full time

From the posting
About Takeda
For Location
USA - MA - Alewife - BIO OPS
Job Exempt
YesIt is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
Equal opportunity, accessibility and legal noticesTakeda's statements, word for word
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.
EEO Statement
Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.
Job intelligence
The context around this role
Live data · October 16, 2026
Salary intelligence
How the pay compares
This role's midpoint is 18% above the US median for Quality Assurance roles at this level.
This roleEmployer provided
Associate & Specialist roles in Massachusetts8 roles publishing pay
Associate & Specialist roles in the US167 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $71,800 | — | $112,860 |
| Massachusetts (middle half) | $68,375 | $77,250 | $85,750 |
| All US (middle half) | $60,250 | $78,500 | $93,750 |
This role: Takeda's own published range. Comparisons: the base pay employers published on open Quality Assurance roles at the same level on Regulatory Jobs, October 16, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Quality Assurance
The general path across 866 open Quality Assurance roles on Regulatory Jobs, with the titles they carry most. Not Takeda's own promotion track.
Career resources on Quality Assurance
Skills DNA
What this role leans on
How many of the posting's 39 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- GMP and compliance14
- Documentation and SOPs9
- Collaboration and leadership8
- Quality systems and risk5
- Lab testing and methods4
- Data and digital systems3
- Investigations and CAPA1
- Validation and qualification1
Regulatory intelligence
The rules behind this role
Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.
- FDA21 CFR Parts 210 and 211(official source, opens in a new tab)FDA current good manufacturing practice for finished pharmaceuticals
- FDAFDA data integrity guidance(official source, opens in a new tab)Data Integrity and Compliance With Drug CGMP: Questions and Answers
From Regulatory News
Manufacturing and quality coverage for this professionCompany hiring pulse
Takeda on Regulatory Jobs
- 40
- Open roles
- 38
- Distinct roles
- 16
- Locations
By discipline
- Regulatory19 48%
- Quality15 38%
- Compliance & Safety5 13%
By level
- Director22 55%
- Senior & Principal9 23%
- Manager5 13%
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Quality Operations, Analyst II, Floor Support at Takeda
Open until filled. $72K–$113K a year, employer provided.

