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 Analyst in our Brooklyn Park office.
Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a Quality Control Analyst I working on the Quality team, you will be empowered to use your analytical skills to conduct critical biological test methods and work on cross-functional efforts, and a typical day will include:
- Perform supportive activities for general lab
readiness, laboratory equipment qualification and method transfers.
- Conduct critical biological test methods including
samples generated for in-process, drug substance and stability.
- Use a variety of laboratory instrumentation and
computer systems to collect and record data (such as LIMS).
- Follow SOPs to perform methods requiring precise
analytical skills and understanding of biology and chemistry principles.
- Demonstrate a functional understanding of a
laboratory setting and Standard Operating Procedures (SOPs).
- Complete all testing, including special project /
protocol testing in a timely and appropriate manner.
- Maintain data integrity and ensure compliance with
company SOPs, specifications and cGMP regulations.
judgment within defined Quality Control procedures and practices to
determine appropriate action.
- Initiate low severity level deviations, CAPAs and
change controls within the electronic Quality Management System.
- Occasionally participate in functional efforts
involving teams to solve problems of moderate scope where analysis of
situations or data requires a review of identifiable factors.
- Author minor revisions to existing SOPs.
- Receives general instructions on routine work and
detailed instructions on new assignments.
- May be required to work overtime or be assigned to a
different shift as needed.
- May perform equipment maintenance and calibrations
- May perform other duties as assigned.
EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS:
Bachelor s or Master s Degree in any Life Sciences with relevant laboratory coursework and 0-3 years of relevant experience.
- Previous experience in a regulated environment desirable.
- 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.
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
- Total Organic Carbon Analysis
- 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.
- Willingness to travel to various meetings or training, this could include overnight trips.
- Requires approximately 5% travel.
WHAT TAKEDA CAN OFFER YOU:
401(k) with company match and Annual Retirement Contribution Plan
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.