Are you looking for a patient-focused company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda. Join us as a QC Manager in our Brooklyn Park, Minnesota office.
Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a Quality Control Manager working on the Quality team, you will be empowered to supervise QC Analysts and impact QC processes, and a typical day will include:
- Supervise and mentor QC Analysts on a daily basis.
- Responsible for leading and managing complex projects of diverse scope within QC and cross-functionally.
- Proactively plans and prioritizes lab operations, managing operational efficiency and budget.
- Independently exercises judgment for broadly defined practices, procedures and policies to select methods, techniques and evaluation criterion.
- Decisions have a high impact on future Quality Control processes and procedures and may affect other departments within the organization.
- Uses judgment and experience to troubleshoot problems and formulate solutions and resolve quality and compliance issues.
- Use a variety of laboratory instrumentation and computer systems to review data (such as LIMS).
- Represent QC business processes and needs within the department and at cross functional forums as a technical expert
- Apply knowledge of cGMPs on a daily basis.
- Manage day-to-day operations independently.
- Demonstrate a practical understanding of laboratory operations, systems, methods and regulatory compliance.
- Demonstrate an understanding of company priorities, objectives and project timelines. This includes understanding how QC activities affect the business.
- Demonstrate a thorough theoretical understanding and sound scientific judgment to assess analytical outcomes, data and results, and direct work actions.
- Interact with management to review FTE requirements, annual budgeting and other business needs.
- Responsible for maintaining a compliant training program to ensure analysts are trained on assays, equipment and procedures prior to executing tasks within the lab.
- Proactively identifies ways to improve systems, workflow and overall efficiency in the lab and takes the appropriate action to implement change. This includes performing assay and laboratory system assessments, independently, or as a team leader.
- Works with analysts to qualify, optimize and validate applicable assays, equipment and laboratory systems.
- Works with analysts and employees from other departments to troubleshoot problems of broad scope that encompass multi-faceted project/experimental areas.
- Ensure analysts have an appropriate functional and theoretical understanding of assays by establishing a training curriculum.
- Review SOPs, studies, validation documentation, change controls and investigations to maintain compliance.
- Demonstrates an understanding of how analytical method performance impacts the business.
- Delegate responsibility and projects to QC Analysts based on their level of judgment and experience.
- Meet with individual employees on a regular basis to discuss, prioritize, and assign laboratory work and projects.
- Meet with functional group on a regular basis to discuss routine laboratory functions, individual projects and departmental goals.
- Independently manage personnel development, annual performance reviews and performance issues with minimal guidance.
- Proactively looks for ways to challenge analysts and create career opportunities to enhance job satisfaction and improve the department as a whole.
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
Bachelors or Master’s Degree in any Life Sciences with relevant laboratory coursework and 8+ years of relevant experience, 3+ years supervisory experiencepreferred..
- Previous industry experience in a regulated environment highly desired.
- Ability to handle multiple tasks concurrently, and in a timely fashion.
- Must have basic understanding of laboratory instrumentation.
- Must be able to communicate effectively with supervisors and peers.
- Must be able to read, write and converse in English.
- Must be computer literate. Able to navigate, conduct searches, and complete online forms on Personal Computer for the purposes of training, performance management, and self service applications.
- Good interpersonal skills and be able to work effectively and efficiently in a team environment.
- Knowledge of cGMP manufacturing preferred.
- Knowledge of basic chemical and biological safety procedures.
- Must display eagerness to learn and continuously improve.
- Must have the following personal attributes: integrity and trust, work ethic, sound judgment, intellectual honesty, pragmatism, courage and conviction.
- In general, the position requires a combination of sedentary work and standing for extended periods of time in the Quality Control labs.
Job ID R0006558