Hiring company: Takeda
About the role:
You will perform tasks to support the site's Document Control and archival systems. This includes staffing the site's secure document vaults and maintaining inventory control; global Document Management System administration and document lifecycle oversite and troubleshooting; document revision support of formatting, processing, and content clarification. You will maintain expertise in use of global document management system; trains and aids site personnel related to the system. You will report directly to the Supervisor, Quality Assurance.
How you will contribute:
- Monitor metrics and escalate issues and support other Quality Systems.
- Proficient in documentation change management, documentation lifecycle, and record retention.
- Maintain local Document Vaults including document inventory, vault audits, off site storage inventory, supplies, drop off / checkout processes.
- Ensure global requirements are met. Apply local standards for document content, lifecycle management, and our requirements.
- Aid document and department owners during document periodic reviews on improvements needed in document or related documents.
- Maintain metrics
- Apply templates, write and review existing documents (Standard Operating Procedures, job aid, form, OJT, logbooks, and reports)
- Support new approaches to related our processes such as Good Practices (GxP) documentation, documentation management, record retention, end-user experience/needs
- Provide training to our personnel on documentation and archival related processes and systems.
- Maintain and own internal documents.
- Perform/support internal assessments by collecting and analyzing accurate, objective evidence regarding risks and their magnitude. Maintain expertise in quality systems and quality techniques.
- Maintain expertise in current regulatory requirements and technical issues. Participate in QA/QC site or multi-site projects in the role of contributor or coordinator.
- Help train staff, our customers and assure training requirements are met and records are up-to-date.
What you bring to Takeda:
- High school and 4 or more years' experience with Baxter Product Data Management/documentation systems or equivalent change control system.
- Knowledge of document processing and management
- Intermediate level desktop publishing skills and document management (e.g. Word) software skills.
- Computer experience and have knowledge of FDA Regulations, Application of Good Laboratory Practices, and Application of Good Manufacturing Practices
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 create quality products and we aim to create a safe environment for our team members. As a result, we must follow strict rules in our manufacturing facilities to ensure we are not endangering the quality of the product or putting anyone at the site in harm's way. 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.
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.