Takeda · 6 hours ago
Deviation Investigator – Quality Control
Brooklyn Park, MN
Full-time
Onsite
Mid, Senior Level
$86K/yr - $136K/yr
5+ years expTakeda is transforming patient care through the development of novel specialty pharmaceuticals. As a Deviation Investigator - Quality Control, you will perform deviation investigations, CAPAs, and change controls while ensuring compliance with quality metrics and standards.
BiotechnologyHealth CareManufacturingMedicalPharmaceutical
Responsibilities
Operate Brooklyn Park EQMS (e.g., processing of applicable Help Desk Tickets, Administration of user accounts and EQMS user roles)
Monitor the EQMS for compliance with procedures, and completion of deliverables according to committed timelines. Track progress against baseline metrics
Lead Global EQMS projects related to EQMS topics (e.g., Community of Practice, workstream participation)
Review and write deviations, investigations, change controls and CAPAs associated with cGMP compliance
Review and approve deviations for compliance to IQS standards
Identify, investigate, and resolve complex technical issues using problem-solving skills
Analyze and interpret projects, studies, or investigations to determine next steps
Write and revise documents independently
Perform QA review/approval of controlled documents ie. Veeva workflows
Participate in internal or supplier audits
Develop and provide training on department-specific procedures and systems ie. Deviations, IQS
Participate in required training and keep training files current
Identify, propose, and implement Quality Process and system improvements
Help implement global QA approaches based on sound principles, international industry/regulatory standards, and scientific basis
Assist in troubleshooting issues related to quality concerns, implementing solutions and corrective actions
Qualification
Required
BA/BS required. Life Science discipline would be ideal
5+ years' experience in Regulated (food, medical device, or pharma/biotech) industry preferred
Direct experience with Quality Assurance within the Life Science industry strongly desired
Understand and apply comprehensive knowledge of quality and GMP principles. Maintain current understanding of global GMP regulations
Must be experienced in Microsoft Office applications, especially Word, Excel, and PowerPoint
Identify, investigate, and resolve complex technical issues using problem-solving skills
Analyze and interpret projects, studies, or investigations to determine next steps
Write and revise documents independently
Perform QA review/approval of controlled documents ie. Veeva workflows
Participate in internal or supplier audits
Develop and provide training on department-specific procedures and systems ie. Deviations, IQS
Participate in required training and keep training files current
Identify, propose, and implement Quality Process and system improvements
Help implement global QA approaches based on sound principles, international industry/regulatory standards, and scientific basis
Assist in troubleshooting issues related to quality concerns, implementing solutions and corrective actions
Preferred
Previous experience with the following would be ideal. This includes Auditing, basic statistics, and Peer review/approval of documentation
Experience with Quality Training, Quality Improvement Tools, and Supplier Quality is desired
Technical Writing and Review, and Writing/reviewing/approving investigations, are also valuable
Benefits
Medical, dental, vision insurance
401(k) plan and company match
Short-term and long-term disability coverage
Basic life insurance
Tuition reimbursement program
Paid volunteer time off
Company holidays
Well-being benefits
Up to 80 hours of sick time
Up to 120 hours of paid vacation
Company
Takeda
Takeda is a biopharmaceutical company that researches and develops pharmaceutical drugs.
10001+ employees
H1B Sponsorship
Takeda has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (45)
2024 (39)
2023 (38)
2022 (34)
2021 (44)
2020 (18)
Funding
Current Stage
Public CompanyTotal Funding
$2.46B2025-06-27Post Ipo Debt· $2.4B
2016-09-01Grant· $19.8M
2016-05-08Grant· $38M
Leadership Team
Christophe Weber
President and CEO
Schuyler Fairfield
Senior Vice President, Global Head of Supply Chain
Recent News
2026-01-25
legacy.thefly.com
2026-01-23
2026-01-22
Company data provided by crunchbase