Lead Quality Control Technician

About the Role:

Conducts and performs a wide range of biological, chemical, or physical analyses on pharmaceutical products (biologics and drugs) through all stages of the manufacturing process from incoming raw materials to finished goods, and may include environmental monitoring programs. You may be applicable to QC Analytical or Microbiological testing, Compliance, QCMIS, or Laboratory Operations.

How you will contribute:

• Assist in the development of lab test methods on raw materials, initial, in-process and final products, and samples collected from environmental monitoring programs at Takeda manufacturing facilities. Work under minimum supervision.
• Assist with the installation and validation of sophisticated laboratory instrumentation and computer systems to collect and record data. Perform advanced assays requiring precise analytical skills and understanding of microbiology and chemistry principles.
• Complete all testing, including special project / protocol testing in a timely and appropriate manner.
• Maintain data integrity and ensure compliance with company SOPs and specifications, FDA, GLP, QSR and cGMP regulations.
• Investigate deviations and write exception documents.
• Participate in functions involving teams, which impact production, increase efficiency, solve problems, generate cost savings and improve quality.
• Perform laboratory and manufacturing audits as required. Audit and update, as required, plant SOPs.
• Perform equipment maintenance and calibrations as required.

What you bring to Takeda:

• Bachelor’s Degree in Chemistry, or Biological Science with Analytical Chemistry or Microbiology Laboratory coursework and 0-2 years’ experience
• Proficient in wet and instrumental methods of analyses.
• Advanced laboratory skills and basic knowledge of statistical method.
• Strong technical problem solving skills
• Ability to handle multiple tasks concurrently, and in a timely fashion.
• Must communicate effectively (verbal and written) with supervisors and peers.
• Must demonstrate effectiveness in ability to train others
• Knowledge of most laboratory equipment including but not limited to autoclaves, incubators, analytical equipment
• Must be proficient in a variety of mathematical operations and calculations and be able to work with both the metric and US standards of measurement.
• Must be able to read and follow detailed written instructions and have good verbal/written communication skills.
• Knowledge of basic chemical and biological safety procedures.
• Good computer skills, knowledge of Microsoft Word, Excel and Powerpoint.

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 product. 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 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.

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.