Senior Quality Control Analyst - Microbiology
Brooklyn Park, Minnesota
Takeda fosters a collaborative and stimulating work environment filled with opportunity and the chance to make a difference in people's lives. It is a workplace driven by integrity, one of Takeda’s long-held values that extends to both the patients we serve and our employees who develop and deliver medicines. Across our company, Takeda employees bring together diverse strengths that together create a stronger whole.
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Takeda’s Brooklyn Park manufacturing facility provides long-term strategic benefits by enhancing Takeda’s capacity to manufacture additional commercial products and investigational drugs under clinical development. This plant allows Takeda to establish and develop direct commercial bio-manufacturing expertise, and is poised to be a world-class biologics drug substance production facility. When fully constructed, it will be a 215,000 square-foot facility manufacturing multiple antibody products, including Entyvio.
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Senior Quality Control Analyst - MicrobiologyApply Now
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 Sr Quality Control Analyst in our Brooklyn Park, Minnesota office.
Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a Sr QC Analyst working on the Microbiology team, you will be empowered to work on complex projects and represent QC business processes, and a typical day will include:
- Responsible for coordinating or contributing to complex projects of moderate scope within QC and cross-functionally.
- Perform activities for general lab readiness, laboratory equipment qualification and method transfers.
- Use a variety of laboratory instrumentation and computer systems to review data (such as LIMS and Empower).
- Independently apply scientific judgment to QC laboratory work and contribute to milestones related to specific projects.
- Represent QC business processes and needs within the department and at cross functional forums.
- Demonstrate functional versatility and perform work on complex problems of broad scope that encompass multifaceted project and methodological areas.
- Maintain data integrity and ensure compliance with company SOPs, specifications and cGMP regulations.
- Decisions have a high impact on future Quality Control processes and procedures and may affect other departments within the organization.
- Proactively participate in the planning and prioritization of lab operations and/or the resolution of quality and compliance issues.
- Participate in software/equipment qualification.
- Initiate and own deviations, CAPAs and change controls within the electronic Quality Management System.
- Proactively revises and authors new SOPs and study documentation.
- Independently executes activities without supervisor guidance.
- Provides mentoring, training and may serve as Lab Lead to direct work of lower level QC Analysts.
- Lead projects and coordinate projects with other departments.
- Recognized as a technical expert within QC and outside the department. Demonstrates an understanding of how method performance impacts the larger business scope.
- May be responsible for administration of laboratory systems.
- May perform other duties as assigned.
EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS:
Bachelors or Master’s Degree in any Life Sciences with relevant laboratory coursework and 8+ years of relevant experience.
- Previous industry experience in a regulated environment highly desired.
- Ability to handle multiple tasks concurrently, and in a timely fashion.
- Must have understanding of laboratory instrumentation.
- Must be able to communicate effectively with managers 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 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.
The familiarity or experience with the following assays:
- Aseptic Technique
- Environmental Monitoring (including viable air monitoring, non-viable air monitoring, surface monitoring and clean compressed air)
- Water sampling
- Organism Identification
- Gram Stain
- Biological Indicator Testing
- Growth Promotion
- 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
No Phone Calls or Recruiters Please.
Brooklyn Park, MN
Job ID R0005451