Quality Systems Analyst III
Company: Biolife Plasma Services
Posted on: May 12, 2022
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
that all information I submit in my employment application is true
to the best of my knowledge.Job DescriptionAbout 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.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
- 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
- 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
- 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
- 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
- Be An Excellent Manager of Self and Others
- Ability to drive decisions through Influence
- Ability to manage, prioritize and deliver on core
responsibilitiesDecision-making and Autonomy
- Support Management Review metrics, document control, inspection
- 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
- Ability to work independently or in team environment, with
- 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
- Open to new and innovative approaches for continuous
- 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
- Effective organizational, technical and problem-solving
- Must have computer proficiency and able to utilize MS Office
software (e.g., MS Word, MS PowerPoint, MS Excel) at an advanced
level.EEO StatementTakeda 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.LocationsBannockburn, ILWorker TypeEmployeeWorker
Sub-TypeRegularTime TypeFull time
Keywords: Biolife Plasma Services, Evanston , Quality Systems Analyst III, Professions , Evanston, Illinois
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