Quality Control Analyst II - Microbiology
Location:
Brooklyn Park , Minnesota
Posted:
December 12, 2017
Reference:
1702537

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 II in our Brooklyn Park, MN office.

Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a Quality Control Analyst II working on the Brooklyn Park team, you will be empowered to use your analytical skills to conduct critical biological test methods and work on cross-functional site efforts, and a typical day will include:

  • This position will 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 routine and non-routine methods requiring precise analytical skills and understanding of biology and chemistry principles.


POSITION ACCOUNTABILITIES:

  • Demonstrate a functional and basic theoretical understanding of laboratory operations 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 generally defined Quality Control procedures and practices in selecting methods and techniques to troubleshoot problems and/or formulate solutions.
  • Decisions have moderate impact on future Quality Control processes and procedures.
  • Initiate and own deviations, CAPAs and change controls within the electronic Quality Management System.
  • Occasionally participate in cross-functional efforts involving teams.
  • Drafts studies and investigations of moderate scope and works on problems in which the analysis of the situation or data requires a review of identifiable factors.
  • Authors new SOPs and initiates changes to existing procedures.
  • Receives general instructions on new assignments and limited instruction on routine work.
  • May assist in training new QC Analysts on routine procedures and practices.
  • May be required to work overtime or be assigned to a different shift as needed.
  • May perform equipment maintenance and calibrations as required.


Qualifications:


REQUIRED QUALIFICATIONS:

  • Bachelor’s or Master’s Degree in any Life Sciences with relevant laboratory coursework and 3-6 years of relevant experience.
  • 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 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.


SKILLS:


  • Previous experience in a regulated environment desirable.
  • Knowledge of cGMP manufacturing preferred.


MICROBIOLOGY SKILLSET

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
  • Validation of microbiological methods


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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*LI-MJ1-USA

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