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Job Description

Process Documentation Specialist II

Alewife, MA

About the role:

Join Takeda as a Process Documentation Specialist II where you will oversee the development, creation, and revision of controlled manufacturing documentation in accordance with GMP standards . You will also lead while partnering with SMEs from cross-functional teams to ensure that all controlled documents being created or revised contain relevant information about process, product, and equipment specifications and are completed within defined timelines. As part of the Process Documentation team, you will to the Manufacturing Documentation Manager and work with various teams.

How you will contribute:

• You will manage document lifecycles within the electronic documentation systems per applicable procedures, this will include creating and revising documents as guided by project needs, technical transfers and change management systems.
• You will create and revise SOPs, Batch Records and Form Preps; Identify and lead required documentation revisions within the electronic documentation system
• You will ensure consistency and understanding between documents in compliance with SOP requirements
• You will address comments as provided by document reviewers
• You will provide expertise and use best practices to technicians and support groups when reviewing draft SOPs and Batch Records/Form Preps
• You will coordinate with the training group to ensure appropriate training materials are created with new or revised GMP documentation projects or change management

Minimum Requirements/Qualifications:

• Bachelor’s degree (or equivalent combination of education and relevant experience
• 3 or more years experience
• Previous technical writing experience required
• Ability to manage complex projects
• Prioritize multiple tasks and projects
• Must be proficient with Microsoft Office applications, including Word, Excel, Power Point. Working knowledge of electronic document management applications is required
• This is hybrid position that requires time on-site during the week.

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
• Flexible Work Paths
• Tuition reimbursement

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.

In accordance with the CO Equal Pay Act, Colorado Applicants Are Not Permitted to Apply.

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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 – Alewife – BIO OPS

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time