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Job Description

About the role:

The Sterility Assurance Senior Analyst ensures the quality of processes and product outputs by defining activities processes and standards to meet quality requirements. This role involves auditing monitoring and determining the quality of processes or outputs against defined internal and regulatory standards contributing to Takedas mission of delivering high-quality products. The incumbent will provide quality oversight of the laboratory and manufacturing operations in addition to implementing and maintaining an effective quality control program in alignment with internal company standards and current industry practices. This employee will typically focus on disciplines related to environmental monitoring laboratory methods contamination control strategies and pharmaceutical microbiology.

How you will contribute:

• 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 decisionmaking 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 paperbased forms to enhance accuracy speed and overall operational performance.

What you bring to Takeda:

• Typically requires bachelors degree in science engineering or other related technical field. 3 years of related work experience. Bachelors 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.

• 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.

Important Considerations:

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:

• Work in a controlled environment requiring special gowning and wear protective clothing over the head face hands feet and body. This may include additional hearing protection for loud areas.

• Need to remove all make-up jewelry contact lenses nail polish and/or artificial fingernails while in the manufacturing environment.

• Work in a cold wet environment.

• Work multiple shifts including weekends or be asked to work supplemental hours as necessary.

• Work around chemicals such as alcohol acids buffers and Celite that may require respiratory protection.

• The candidate must not be allergic to Cephalosporin drugs.

• Ability to walk 1-3 miles and lift 10 lbs. during a workday is required.

• Indoor working conditions

• Will work around moving equipment and machinery

• May be required to work in controlled environments requiring special safety gear or gowning; will be required to follow gowning requirements and wear protective clothing over the head face hands feet and body. No make-up jewelry nail polish or artificial fingernails may be worn in the manufacturing environment.

• May be required to work in confined spaces/areas.

• Some Clean Room and/or cool/hot storage conditions.

• Must be able to work on multiple shifts including weekends to support a 24/7 manufacturing operation as needed.

• Must be able to work non-traditional work hours or work extended hours including weekends and holidays as needed.

More about us:

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-MA1

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.

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Job Exempt