Manufacturing Support Specialist I

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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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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 - Lexington - BIO OPS
Worker Type
Employee
Worker Sub-Type
Regular
Time Type
Full time