Quality Specialist III

About the Role

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.
• Perform document reviews thoroughly, with high attention to detail, using extensive working knowledge of quality concepts and internal procedures and controls.
• Analyze and interpret projects, studies, or investigations to determine next steps.
• Make decisions independently and notify management of actions taken.
• Identify, investigate, and resolve 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 Level1 and 2 Change Controls.
• Investigate and own quality events (deviations, CAPAs, and Level1 or 2 Change Controls) for quality‑related topics.
• Write new documents and revise existing documents independently.
• Develop and provide training on department‑specific procedures and systems.
• Train and mentor 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.
• Make informed, data‑based decisions utilizing a risk‑based approach.
• Complete mandatory training within the required timeframe.
• Perform additional duties as assigned.

• BA/BS (or Master’s) in any Life Science discipline preferred, and/or 5+ years’ experience in a regulated industry (food, medical device, or pharma/biotech).
• Direct experience with quality in a regulated industry.
• Comprehensive knowledge of quality and GMP principles.
• Experience 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; monitoring and reporting 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.

• 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.
• Experienced in Microsoft Office applications, especially Word, Excel, and PowerPoint.
• Experience with Electronic Quality systems (e.g., SAP, PAS‑X, Track Wise).
• Preferred Certified Quality Auditor (CQA) or other ASQ certifications.

Must be able to remain in a stationary or standing position for extended periods of time. May be required to wear personal protective equipment and other clean‑room garments daily, including 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 support a 24‑7 manufacturing department.

Willingness to travel to various meetings or training, which may include overnight trips.

Takeda is proud of 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, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws.