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.

Job Description

Process Documentation Specialist II

Lexington, 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 observing GMP standards. You will also lead while partnering with SMEs from cross-functionals team to ensure that all controlled documents being created or revised contain important information on process, product, and equipment specifications are completed within timelines. As part of the Process Documentation team , you will report to the Technical Documentation Manager and work with several groups within the facility.

How you will contribute:

• You will create SOPs, batch records and Form Preps: identify and lead required documentation revisions within the electronic system


• You will ensure consistency and agreement between documents in compliance with SOP requirements


• You will provide expertise and use best practices to technicians and support groups when reviewing draft SOPs, batch records, and form preps


• You will monitor and trend effectiveness of documentation modifications and look for areas of improvement to increase efficiencies and decrease document cycle times


• You will coordinate with the training group to ensure appropriate training materials are created with new or revised GMP documentation projects or change management


• You will manage complex projects and drive results

• Bachelors degree with 2+ years' relevant experience in a life sciences related field


• Experience supporting continuous improvement efforts to ensure documentation id efficient and compliant


• Experience overseeing quality and effectiveness of important results of major projects within function through sound planning and implement a fallback strategy

• 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

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.

#GMSGQ

#ZR1

#LI-MA1

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