Takeda · 21 hours ago
Sterility Assurance, Senior Analyst
USA - IL - Round Lake - Drug Delivery
Full-time
Onsite
Mid, Senior Level
$86K/yr - $136K/yr
3+ years expTakeda is a patient-focused company transforming patient care through the development of novel specialty pharmaceuticals. The Sterility Assurance, Senior Analyst ensures the quality of processes and product outputs by defining activities and standards to meet quality requirements, while providing quality oversight of laboratory and manufacturing operations.
BiotechnologyHealth CareManufacturingMedicalPharmaceutical
Responsibilities
Owns Standard Operating Procedures and other Quality Documentation relevant to Quality Control and Sterility Assurance department. Approves Standard Operating Procedures and other Quality Documentation pertinent to all areas of the plant
Develops and delivers training materials relevant to Quality operations. Approves training materials pertinent to all areas of the plant
Owns investigations and CAPAs relevant to Quality Control and Sterility Assurance function
Review and approve documents following cGMP guidelines
Performing data trending and analysis to identify quality shifts, detect potential nonconformances, and support proactive decision‑making to maintain product and process integrity
Participate in internal and external regulatory audits as a SME for Quality Control and Sterility Assurance and present to auditor, if required
Proactively identifies, escalates, and/or resolves potential contamination risk and/or negative trends in quality control data
Exercises judgment for broadly defined practices, procedures, and policies to select methods, techniques, and evaluation criterion
Forward thinking ensures decisions do not negatively impact future Quality processes and procedures and other departments within the organization
Uses judgment and experience to troubleshoot problems and formulate solutions
Coaches and mentors manufacturing personnel on the floor on aseptic awareness and appropriate cleanroom behaviors
Drive continuous improvement initiatives by analyzing current processes, identifying efficiency opportunities, and implementing optimized workflows, including the digitalization and automation of paper‑based forms to enhance accuracy, speed, and overall operational performance
Qualification
Required
Typically requires bachelors' degree in science, engineering, or other related technical field
3+ years of related work experience
Must have knowledge of FDA Regulations, Application of Good Manufacturing Practice, and Good Laboratory Practices
Comprehensive knowledge of aseptic processing of biologic solutions, sterile filtration, Moist Heat sterilization, and Hydrogen Peroxide decontamination processes
Must have working knowledge of current quality control laboratory principles such as Environmental Monitoring, disinfectant efficacy, and Environmental Monitoring Performance Qualification (EMPQ)
Must demonstrate strong leadership, influence, and cross-functional collaboration skills and able to work efficiently in a cross-functional team environment
Skilled in use of electronic word processing, spreadsheet, project management, and presentation tools such as Microsoft Office (Word, Excel, Project, and PowerPoint), and strong knowledge of descriptive statistics
Ability to prioritize and thrive in a fast-paced environment
Strong interpersonal skills and great attention to detail are necessary
Must be a team player with excellent problem solving and critical thinking skills
Demonstrate effectiveness in task completion, decision-making, empowerment of others, deviation/nonconformance management, training, problem solving and team leadership
Strong leadership and collaboration skills with demonstrated success managing a multi-level team
Interacts frequently with internal subordinates, functional peers, and senior group managers
Solid laboratory technical background and knowledge of main analytical tools
Must be proficient in written and oral English
Must be able to handle multiple projects concurrently
Preferred
Bachelor's Degree in Chemistry or Biological Science is preferred
Experience in Environmental Monitoring, Bioburden, and Sterility testing data trending
Experience in method transfer as well as knowledge of equipment and instrument qualification/validation
Experience in implementation and use of electronic laboratory management systems
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