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.
Qualifications: REQUIRED QUALIFICATIONS:
- 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.
- 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.
- Previous experience in a regulated environment desirable.
- Knowledge of cGMP manufacturing preferred.
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
- Validation of microbiological methods
In general, the position requires a combination of sedentary work and standing for extended periods of time in the Quality Control labs. TRAVEL REQUIREMENTS:
WHAT TAKEDA CAN OFFER YOU:
- Willingness to travel to various meetings or training, this could include overnight trips.
- Requires approximately 5% travel.
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.
- 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
A little about us:
Takeda fosters an inclusive environment where all employees are empowered to shine.