Team Lead Quality Control - Microbiology


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 Quality Control Team Lead in our Brooklyn Park, Minnesota office.


Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a QC Analyst Team Lead working on the Microbiology team, you will be empowered to supervise QC Analysts and impact QC processes, and a typical day will include:


OBJECTIVES:
•Supervise and mentor QC Analysts on a daily basis.
•Independently exercises judgment for broadly defined practices, procedures and policies to select methods, techniques and evaluation criterion.
•Decisions have an 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.
•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.


ACCOUNTABILITIES:
•Demonstrates theoretical understanding of laboratory operations, systems, methods and regulatory compliance.
•Analyzes and interprets projects, studies, or investigations to determine next steps. Makes decisions independently and notifies management of action taken.
•Responsible for ensuring analysts are trained on assays, equipment and procedures prior to executing tasks within the lab.
•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.
•Works with analysts to qualify, optimize and validate applicable assays, equipment and laboratory systems.
•Review SOPs, studies, validation documentation, change controls and investigations to maintain compliance.
•Demonstrates an understanding of how analytical method performance impacts the business.
•Apply knowledge of cGMPs on a daily basis.
•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.
•Manage personnel development, annual performance reviews and performance issues with Management guidance.
•Proactively looks for ways to challenge analysts and create career opportunities to enhance job satisfaction and improve the department as a whole.
•Receives minimal supervision on work assignments. Receives overall project direction from management but completes most work independently.
•Participates in internal audits as needed.
•May be responsible for administration of laboratory systems.
•May perform other duties as assigned.
•Team lead will support weekends at our 24/7 manufacturing facility. Hours are first shift, working a five day schedule that includes Saturday and Sunday support.


EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS:


Bachelors or Master’s Degree in any Life Sciences with relevant laboratory coursework and 8 years of relevant experience, 3 years supervisory experience preferred.
•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 Managers, peers, and direct reports.
•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.


MICROBIOLOGY SKILLSET


The familiarity or experience with the following assays:
•Aseptic Technique
•Bioburden
•Environmental Monitoring (including viable air monitoring, non-viable air monitoring, surface monitoring and clean compressed air)
•Water sampling
•Endotoxin
•Microscopy
•Organism Identification
•Gram Stain
•Biological Indicator Testing
•Growth Promotion



PHYSICAL DEMANDS:
•In general, the position requires a combination of sedentary work and standing for extended periods of time in the Quality Control labs.



WHAT TAKEDA CAN OFFER YOU:

•401(k) with company match and Annual Retirement Contribution Plan
•Tuition reimbursement
•Company match of charitable contributions
•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


Empowering Our People to Shine


Learn more at takedajobs.com.


Takeda is an EEO employer of minorities, women, disabled, protected veterans, and considers qualified applicants with criminal histories in accordance with applicable laws. For more information, visit http://www.takeda.us/careers/EEO_Policy_Statement.aspx

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