Quality Specialist III

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Perform Quality activities associated with cGMP biologics intermediate and/or drug substance manufactured at the Takeda Brooklyn Park Site. Focused primarily on providing support and guidance on complex and non-routine quality-related issues

• Follow all established written procedures. Drive the assessment and implementation of global and local policies guidance documents standards and procedures governing cGMP work performed at the site.
• Performs documentation review thoroughly with a high attention to detail using extensive working knowledge of quality concepts and internal procedures and controls.
• Analyzes and interprets projects studies or investigations to determine next steps. Makes decisions independently and notifies management of action taken.
• Identifies investigates and resolves complex technical issues using problem-solving skills.
• Actively engage with the local team to prioritize and complete activities to support the site goals.
• Review/approve document workflows low/medium-risk Deviations CAPAs and Level 1 and 2 Change Controls.
• Investigate/own quality events (deviations CAPAs and Level 1 or 2 Change Controls) for quality-related topics.
• Writes new documents and revises existing documents independently.
• Develops and provides training on department-specific procedures and systems. Trains and mentors peers.
• Contribute to and share best practices in global engagement activities (community of practice) for quality related topics.
• Drive a Continuous Improvement mindset to identify and propose Quality Process and system improvements to meet department/site KPIs.
• Makes informed data-based decisions utilizing a risk-based approach.
• Complete mandatory training within required timeframe.
• Performs additional duties as assigned.
• Employee at this level is involved in routine and non-routine tasks of complex scope.
• Employee executes on new work and refers to policies and procedures for guidance.
• Responsible for conducting independent work with minimal guidance from trainers and more senior staff.
• Responsible for contributing to moderate scope decisions founded on GxP principles local/global procedures robust scientific basis and utilizing the concepts of PTRB (Patient-Trust-Reputation-Business).
• Cross-functional key collaborator to achieve site goals.

• BA/BS (or Masters) in any Life Science discipline preferred and/or 5 years experience in Regulated (food medical device or pharma/biotech) industry.
• Must have direct experience with quality in a regulated industry.
• Understands and applies comprehensive knowledge of quality and GMP principles.
• Experience with the following is preferred: Basic statistics; Internal / External Auditing; Change management Peer review/approval of documentation; Quality Training; Quality Improvement Tools (Risk Assessments flowcharts root cause analysis); Supplier Quality; Technical Writing and Review; Writing/reviewing/approving investigations; Monitor and report KPIs.
• Ability to perform multiple tasks concurrently and in a timely fashion.
• Good interpersonal skills and ability to work effectively and efficiently in a team environment to accomplish goals and drive issue resolution.
• Excellent verbal and written communication skills and ability to communicate effectively with site personnel peers and management.
• Must be able to read write and converse in English.
• Must display eagerness to learn teach and continuously improve.
• Positive work attitude that supports teamwork and continuous improvement.
• Quality Assurance Proficient knowledge of manufacturing and/or lab processes batch record review batch disposition material hold change management and document workflows and Quality on the Shop Floor. Proficient knowledge in the management of the Deviation/CAPA/Change Control systems and document workflows
• Must be experienced in Microsoft Office applications especially Word Excel and PowerPoint.
• Experience with Electronic Quality systems (e.g. SAP PAS-X TrackWise) preferred
• Certified Quality Auditor (CQA) or other ASQ certifications preferred

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 this role you may:

• Stand or sit -> Must be able to remain in a stationary or standing position for extended periods of time.
• Wrist and hand motion (e.g. typing writing). Other / Travel Requirements:
• May be required to wear personal protective equipment (PPE) and other clean room garments daily. This may include safety shoes safety glasses lab coats full body gowns hair nets gloves and hearing protection.
• May be required to participate in an on-call rotation for off-shift coverage or occasionally work off-shift hours to help support a 24-7 manufacturing department.
• Willingness to travel to various meetings or training this could include overnight trips.

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.

#GMSGQ #ZR1 #LI-Onsite

Takeda Compensation and Benefits Summary

We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees and we strive to be more transparent with our pay practices.

For Location:

U.S. Base Salary Range:

The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors including the qualifications of the individual applicant for the position years of relevant experience specific and unique skills level of education attained certifications or other professional licenses held and the location in which the applicant lives and/or from which they will be performing the actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.

U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medical dental vision insurance a 401(k) plan and company match short-term and long-term disability coverage basic life insurance a tuition reimbursement program paid volunteer time off company holidays and well-being benefits among others. U.S. based employees are also eligible to receive per calendar year up to 80 hours of sick time and new hires are eligible to accrue up to 120 hours of paid vacation.

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.

Job Exempt