Quality Control Analyst I - Microbiology
Location:
Brooklyn Park , Minnesota
Posted:
February 20, 2018
Reference:
1703126

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.

H ere, 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:

POSITION OBJECTIVES:

  • 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.


POSITION ACCOUNTABILITIES:

  • 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.
  • Exercise 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 as required.
  • May perform other duties as assigned.




Qualifications:


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.


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
  • Total Organic Carbon Analysis
  • Conductivity
  • Microscopy
  • Organism Identification
  • Gram Stain
  • Biological Indicator Testing
  • Growth Promotion
  • Osmolality
  • Glucose/Glutamine


LICENSES/CERTIFICATIONS:
  • NA


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


TRAVEL REQUIREMENTS:

  • 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
  • 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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A little about us:
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