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Corporate Opportunities

Quality Systems Analyst

Bannockburn, Illinois
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Job ID R0071309

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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 is quality oversight and management of design, development, verification and validation activities for GxP and non-GxP computer systems, and backup support for Blood Establishment Computer Software (BECS) classified as a medical device.
  • Defining systems scope and objectives based on both user needs and a good understanding of applicable business systems, SDLC methodolgy, design control processes, industry requirements, as well as product support processes.
  • Work closely with application development, validation and end users groups to design and validate new systems or modify existing systems.
  • Manage new plasma center startup tasks in the quality role related to review of installation/qualification/facility validation of medical devices and non-medical device computer systems.

ACCOUNTABILITIES

  • 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.
  • Provide guidance in interpretation and correct application of 21 CFR Part 11 regulations in new and existing systems.
  • Support documentation updates and performance of system verification and validation testing.  Review validation or other computer system records to ensure they are complete, accurate and compliant with cGMP requirements.
  • Understand and follow appropriate SDLC, quality validation processes and application processes. Provides support to business function and IT concerning quality issues and ensures conformance to established performance requirements and procedures.
  • Own key tasks, with little direction; handle complex problems and identify solutions or corrections.
  • Stays current with federal, state, local and company-specific rules, regulations and practices.

DIMENSIONS AND ASPECTS

Technical/Functional (Line) Expertise

  • Support the change control, medical device complaint processes ensuring compliance to the 21 CFR Part 820 Quality System Regulation.

Leadership

  • Follow and display the Takeda Values of Integrity, Fairness, Honesty, and Perseverance.
  • Exhibit behaviors to support the Takeda Global Core Competencies to Engage Others, Collaboration,Drive for Results, Strategic Approach, Lead Change, Self-Awareness and Develop Capabilities.
  • Be An Excellent Manager of Self and Others
  • Ability to drive decisions through Influence
  • Self-motivated
  • Ability to manage, prioritize and deliver on core responsibilities

Decision-making and Autonomy

  • Support Management Review metrics, document control, inspection readiness, etc.
  • Review and approve documentation as part of software verification and system verification/validation to ensure it is complete, accurate and compliant with cGMP requirements.

Interaction

  • Ability to work successfully with others and collaborate with cross functional areas to identify needs, provide guidance, and communicate solutions.
  • Ability to work independently or in team environment, with cross-functional groups.
  • Ability to mentor and act as information Quality Resource for lower level and other departmental team members.
  • Support design transfer activities for deployment of computer systems/software devices.

Innovation

  • Open to new and innovative approaches for continuous improvement.
  • Initiating and embracing changes to processes as needed.
  • Confidence to challenge the status quo.
  • Participate in creating a “right first time” environment in everything we do through a focus on simplification, standard work, visual management and communication.

Complexity

  • Ability to handle simple and complex problem solving.
  • Ability to thrive in a dynamic setting.

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

Essential:  Bachelor’s degree in Computer Science or a related field or 3 plus years of systems experience. 

Experience quality professional, software quality assurance and IT systems compliance.

Desired:  Working knowledge of 21 CFR Parts 504, 803, 807, 820, 11, FDA Design Control Guidance, FDA General Principals of Software Validation, FDA Guidance Related to 510K Submissions and ISO 13485.

  • Knowledge and experience with Software Development Life Cycle (SDLC) and Verification/Validation techniques.
  • Proficient in TrackWise and knowledge of Quality Systems workflows is preferred.
  • Good Data and Documentation Practices (GDDP) a must
  • Strong written and oral communication skills required, leadership, influencing and project management skills
  • Understanding of relational databases required.
  • Must be detailed oriented and be able to work in a team setting.
  • Effective organizational, technical and problem-solving skills.
  • Must have computer proficiency and able to utilize MS Office software (e.g., MS Word, MS PowerPoint, MS Excel) at an advanced level.

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
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1. Your Initial Application

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2. Your First Review

One of our Hiring Managers will review your application and reach out to you if we think you’re a good fit.

3. Your First Interview

We’ll arrange a time for us to meet virtually or in person. Depending on the role and market, there may be more than one interview.

4. Job Offer

If you’re successful in the interview process, we’ll get in touch with you to make a job offer.

5. Pre-Employment

After electronically accepting your offer, you’ll receive communications electronically which will guide you through the pre-employment process.

6. Onboarding

Once you complete the pre-employment process, we’ll arrange a date for you to join the team, with an onboarding session taking place in your first few weeks at the company.

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