Job Location: Bannockburn, IL
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
About BioLife Plasma Services
Every day at BioLife, we feel good knowing that what we do helps improve the lives of patients with rare diseases. While you focus on our donors, we’ll support you. We offer a purpose you can believe in, a team you can count on, opportunities for career growth, and a comprehensive benefits program, all in a fast-paced, friendly environment.
This position is currently classified as “hybrid” in accordance with Takeda’s Hybrid and Remote Work policy.
BioLife Plasma Services is a subsidiary of Takeda Pharmaceutical Company Ltd.
OBJECTIVES/PURPOSE
- Primary focus of job is managing quality, validation and verification activities supporting regulated software used by Blolife.
- Job includes defining systems scope and objectives based on both user needs and a good understanding of applicable business systems, SDLC, design control processes, and industry requirements.
- Works closely with application development groups and end users to design and validate new systems or modify existing systems.
ACCOUNTABILITIES
- Develop documentation and coordinate validation team In system testing, verification and validation. Review validation or other computer system records to ensure they are complete, accurate, and compliant with cGMP requirements. (40%)
- Analyze business processes and write system documentation including user requirements, risk assessments, and functional specifications. Ensure compliance of system documentation with procedures and regulatory
- requirements. (40%)
- Create test scripts (functional and full path). (10%)
- Work with the business and IT to communicate and discuss quality issues related to software devices and validation. (10%)
- Occasional travel (less than 10%) may be required .
DIMENSIONS AND ASPECTS
Technical/Functional (Line) Expertise
- Strong written and oral communication skills
- Solid understanding of design control process, SDLC, and Verification & Validation techniques
- Demonstrated understanding of quality assurance in an FDA-regulated environment and 21 CFR Part 11
- Understanding of relational databases
Leadership
- Strong leadership abilities
- Strong written and oral communication skills
- Be Results Oriented
- Be An Excellent Manager of Self and Others
- Be Positive
- Be Accountable
Decision-making and Autonomy
- Effective organizational, technical, and problem solving skills
Interaction
- Detail oriented and able to work in a team setting
- Ability to build strong relationships with strong technology application and analytical skills .
- Strong capability to engage, communicate and work effectively with individuals of varying job levels, geographic locations and dispositions.
Innovation
- Open to new ideas
- Embraces change
- Confidence to challenge the status quo
Complexity
- Ability to thrive in a dynamic setting
- Ability to break down complex situations into managable pieces
- Ability to see the big picture and considers upstream and downstream impact of decisions
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
- Bachelor’s degree in Computer Science or a related field or 3+ years of computer systems validation experience.
- Disciplined action and execution, ability to drive operational excellence, promote teamwork, and communicate effectively.
- Ability to build strong relationships with strong technology application and analytical skills .
- Strong capability to engage, communicate and work effectively with individuals of varying job levels, geographic locations and dispositions.
- Aptitude In using Risk Management for decision making and recommendation process .
- Stay current with federal, state, local, and company specific rules regulations and practices .
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
Bannockburn, IL
Worker Type
Employee
Worker Sub-Type
Regular
Time Type
Full time
Submit CV To All Data Science Job Consultants Across United States For Free