Quality Operations, Analyst II, Floor Support

Takeda Pharmaceutical Co.; Cambridge (MA); Presencial; USD 72.000 - 113.000; Jornada completa

Descripción de la vacante

Takeda Pharmaceutical Co. in Massachusetts is seeking a Quality Operations, Analyst II, Floor Support to provide quality oversight in a biotechnology manufacturing environment.

You will collaborate with Manufacturing, Facilities, Engineering, and Regulatory Affairs to maintain inspection readiness and support release of high-quality products. Responsibilites include performing area walkthroughs, reviewing documents, and assisting cross-functional teams in resolving quality and compliance

Formación

• 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 GMP-regulated field.
• Knowledge of GMP, GDP, data integrity, quality systems, and quality risk management.
• Experience with document review and issue resolution.

Responsabilidades

• Provide routine quality oversight and real-time support of GMP manufacturing operations.
• Perform area walkthroughs and compliance assessments to ensure adherence to GMP, SOPs, and regulatory expectations.
• Review and approve documents such as batch records, logbooks, protocols, and reports.

Conocimientos

Quality Assurance

GMP

Documentation

Problem solving

Teamwork

Communication

Attention to detail

Educación

Bachelor's degree in life sciences or related

Herramientas

TrackWise

SAP

LIMS

EDMS

Veeva

Descripción del empleo

Job Description

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 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.

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.

#GMSGQ #ZR1 #LI-MA1

Takeda 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.

For Location:

USA - MA - Alewife - BIO OPS

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.

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.

Locations

USA - MA - Alewife - BIO OPS

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

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.