Quality Control Supervisor

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The Supervisor, Quality Control is in the Quality Control organization at the Takeda Round Lake aseptic pharmaceutical manufacturing facility.  The employee will work as part of cross-functional teams providing quality control oversight of the day-to-day 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.

• Experience in Environmental Monitoring, Bioburden, and Sterility testing data trending.

• Must have knowledge of FDA Regulations, Application of Good Manufacturing Practice, and Good Laboratory Practices.

• Proactively identifies, escalates, and/or resolves potential contamination risk and/or negative trends in quality control data.

• Independently 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 Control processes and procedures and other departments within the organization.

• Uses judgment and experience to troubleshoot problems and formulate solutions.

• Participates in regulatory audits as needed.

• Ability to own and approve root cause investigation related to their area of expertise.

• Ability to coach and mentor manufacturing personnel on the floor on aseptic awareness and appropriate cleanroom behaviors.

• Strong 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

• Highly effective verbal and written communication skills

• Must be able to handle multiple projects concurrently

• Typically requires bachelors’ degree in science, engineering, or other related technical field. 4+ years of related work experience.

• Must be proficient in written and oral English

• In general, the position requires a combination of sedentary work and walking around observing conditions of the facility.

• Must be able to stand and/or walk for an extended period over an 8–12-hour shift between rooms and across the site.

• Comprehensive Healthcare: Medical, Dental, and Vision

• Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan

• Health & Wellness programs including onsite flu shots and health screenings

• Generous time off for vacation and the option to purchase additional vacation days

• Community Outreach Programs and company match of charitable contributions

• Family Planning Support

• Professional training and development opportunities

• Tuition reimbursement

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 product. In this role, you may:

• 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.

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

• May be exposed to and must not be allergic to cephalosporin.

• Must be able to work on multiple shifts, including weekends and holidays, 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. 

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.

This posting excludes Colorado applicants.

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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.

USA – IL – Round Lake – Drug Delivery

Employee

Regular

Full time

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