Job Description

Job Summary:

Primary responsibilities of the position are focused around support of daily manufacturing operations. Primary activities would generally include but not be limited to: investigations and CAPA support, training coordination, document revisions, implementing continuous improvement programs, data analysis/trending, and cross-functional team support. You will report to the Manufacturing Support Manager.

Job Scope:

Provide training to employees and support on Class III deviation investigations.

Help revise controlled documents and training materials to support periodic review, quality system drivers, and continuous improvement projects.

Identify continuous improvement programs to optimize our performance, improve area and campus safety, and bolster operational learning.

Help to lead us towards a culture of safety, innovation, collaboration, best practice, accountability, and efficiency.

How you will contribute:

Partner with cross-functional stakeholders to support data gathering requests for manufacturing investigations, e.g. obtaining copies of production batch records
Help coordinate and implement manufacturing deliverables for quality system drivers, such as investigations and CAPAs
Qualify to perform and train on Class III deviation investigations
Conduct training on manufacturing Class III deviation investigations
Help develop training materials or job aids to support manufacturing learning and execution of Class III deviation investigations
Help coordinate training events, including materials and resources, as applicable
Maintain organizational capability to train on important processes at the site, as applicable

What you bring to Takeda:

Bachelor's degree and 1-3 years industry-related experience OR high school diploma and 5-7 years industry-related experience in cGMP manufacturing
Knowledge of cGMP and other regulatory requirements related to commercial biologics manufacturing
MS Office, LIMS, SAP, TrackWise, EDMS, compliance, and strong scientific understanding
Travel between sites within Massachusetts may be required.
Repetitive bending and reaching to setup and breakdown equipment, if required by specific manufacturing activity.
Ability work around chemicals, if working around the laboratory.
Ability to wear personal protective equipment such as gloves, gowning, and respiratory protection in some cases.
Ability to walk and stand for periods of time.
In general, the position requires a combination of sedentary work, standing work, and walking around facilities.

What Takeda can offer you:

Comprehensive Healthcare: Medical, Dental, and Vision
Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan
Health & Wellness programs including onsite flu shots and health screenings
Generous time off for vacation and the option to purchase additional vacation days
Community Outreach Programs and company match of charitable contributions
Family Planning Support
Professional training and development opportunities
Tuition reimbursement

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:

Work in a controlled environments requiring special gowning. Will be required to follow gowning requirements and wear protective clothing over the head, face, hands, feet and body
No make-up, jewelry, contact lenses, nail polish or artificial fingernails may be worn in the manufacturing environment.
Will work in a cold and/or wet environment.
Must be able to work multiple shifts, including weekends.
Non-Exempt Roles only: Must be able to work overtime as required.
May be required to work in a confined area.
Some Clean Room and cool/hot storage conditions.

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.

This posting excludes Colorado applicants.

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