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Quality Systems and Documentation Coordinator

Takeda Pharmaceuticals
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Job Description

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.
  • Support the preparation, processing, and delivery of quality GxP documentation to the MBO site.
  • Responsible for routine monitoring, reporting and escalation of DMS performance metrics
  • Implement DMS improvement projects and adjust implementation according to prioritization.
  • Provide support to site personnel performing Deviation Investigations, Internal and External audits, CAPAs, and Change Controls as a SME on the DMS.
  • 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).
  • Direct management, organization and maintenance of cross-site controlled document archive rooms.
  • 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
  • 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

 

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:

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

 

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