Job Title: Supervisor, Quality Assurance
Location: Round lake, IL
About the role:
The Quality Assurance (QA) Supervisor will contribute to the development of the Takeda Round Lake site's QC Lab capabilities and will be directly involved in the building, staffing, and qualification of a QC Lab for Analytical and Microbiological testing of all in-process and final container samples and routine environmental monitoring. The QA Supervisor oversees the daily activities related to the Quality Control team. You will provide quality control oversight of the laboratory and manufacturing operations, in addition to implementing and maintaining a quality control program according to internal company standards and current industry practices. You will be focused on disciplines related to environmental monitoring, laboratory methods, contamination control strategies, and pharmaceutical microbiology. You will report on site to the Manager of Quality Assurance.
How you will contribute:
- Staff and manages a team of Quality Assurance Technicians and Analysts. Responsible for the team's continuous development and ensuring they are meeting performance goals.
- Manage Standard Operating Procedures and other Quality Documentation relevant to Quality Assurance department. Approve Standard Operating Procedures and other Quality Documentation important to all areas of the plant.
- Develop and deliver training materials relevant to Quality operations. Approve training materials important to all areas of the plant.
- Manage investigations and CAPAs relevant to quality control function.
- Review appropriate documents following cGMP guidelines and suggest continuous improvement ideas for better processes.
- Participate in internal and external regulatory audits as a SME for Quality control and present to auditor.
- Identify, escalate, and resolve potential contamination risk and negative trends in quality control data.
- Exercise judgment for defined policies to select methods, techniques, and evaluation criterion.
- Ensure decisions do not negatively affect future Quality Control processes and other departments.
- Use judgment and experience to troubleshoot problems and produce solutions.
- Coach manufacturing personnel on the floor on aseptic awareness and appropriate cleanroom behaviors.
- Support continuous improvement projects with the objective of achieving quality, reliability, and cost improvements.
- Experience in Environmental Monitoring, Bioburden, and Sterility testing data trending.
- Experience in method transfer and knowledge of equipment and instrument qualification/validation.
- 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 a working knowledge of current quality control laboratory principles such as Environmental Monitoring, disinfectant efficacy, and Environmental Monitoring Performance Qualification (EMPQ).
- Must demonstrate, influence, and have cross-functional collaboration skills.
- Experience with use of electronic spreadsheet, project management, and presentation tools (Word, Excel, Project, and PowerPoint), and knowledge of descriptive statistics.
- Must be a team player with excellent problem solving.
- Demonstrate effectiveness in task completion, empowerment of others, deviation/nonconformance management, training, problem solving and team leadership.
- Collaboration skills with experience managing a multi-level team.
- Interacts frequently with internal team members, functional peers, and senior group managers.
- Solid laboratory technical background and knowledge of main analytical tools.
- Must be proficient in written and oral English.
What you bring to Takeda:
- Bachelors' degree in science, engineering, or other related technical field.
- 3+ years of related work experience.
- Bachelor's Degree in Chemistry or Biological Science.
What Takeda can offer you:
- 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 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. You may:
- You must not be allergic to Cephalosporin drugs.
- The 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 work in confined spaces/areas.
- Some Clean Room and cool/hot storage conditions.
- 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.
- Will need to remove all make-up, jewelry, contact lenses, nail polish anandrtificial fingernails while in the manufacturing environment.
- May work in a cold, hot or wet environment.
- May work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.
- Will work on multiple shifts, including weekends, to support a 24/7 manufacturing operation.
- Will work non-traditional work hours or work extended hours, including weekends and holidays.
More about us:
At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and the best patient support programs. Takeda is a patient-focused company thtonspire 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.
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.Locations
USA - IL - Round Lake - Drug DeliveryWorker Type