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Job Title: Quality Systems and Documentation Coordinator

Location: Lexington, MA (USA)

About the role:

In this role, you will serve as the Business Administrator and subject matter expert (SME) for Takeda's Documentation Management System (DMS) at the Massachusetts Biologics Operations (MBO) manufacturing site. This is a Hybrid position, and you will report to the Associate Director of QA Compliance.

How you will contribute:

• Be the Business Administrator and subject matter expert (SME) for Takeda's Documentation Management System (DMS) at the Massachusetts Biologics Operations (MBO) manufacturing site.
• Implement DMS improvement projects and adjust implementation according to prioritization.
• Maintain inventory of all records to support retrieval for business use, inspection, and/or destruction, including off-site vendor storage.
• Provide oversite, SME support, and routine maintenance for the Veeva document management system, including heading periodic review and reconciliation for MA Bio Ops
• Support the preparation, processing, and delivery of quality GxP documentation to the MBO site.
• Maintain oversight and management of controlled cross-site production documents to ensure that all documents are managed with cGMP compliance through out their lifecycle (including planning, issuance, storage and archiving).
• Develop and provide training to personnel on records management practices, use of the DMS, quality system specific procedures and systems, creating and maintain system job aides, reference tools, and checklists for the DMS
• Direct management, organization and maintenance of cross-site controlled document archive rooms.
• Responsible for routine monitoring, reporting and escalation of DMS performance metrics
• Provide support to site personnel performing Deviation Investigations, Internal and External audits, CAPAs, and Change Controls as a SME on the DMS.

What you bring to Takeda:

• Bachelor's Degree in Records Management, Library Science or Management Information Systems
• 3+ years of related experience

What Takeda can offer you:

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

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:

• Wrist and hand motion (e.g., typing, writing) while operating office equipment such as computer, phone, calculator, etc.
• Work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.
• Work in a cold, wet environment.
• Work multiple shifts, including weekends, or be asked to work supplemental hours, as necessary.
• Need to remove all make-up, jewelry, contact lenses, nail polish and/or artificial fingernails while in the manufacturing environment.
• 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.
• In general, the position requires mostly sedentary work with occasional walking throughout the facility.

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.

#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