Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Quality Control Analyst I, 2nd Shift in our Brooklyn Park office.
At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.
Here, you will be a vital contributor to our inspiring, bold mission.
As a Quality Control Analyst I, 2nd Shift , working on the team, you will be empowered to help increase quality and service to both internal and external clients. In this role, you will contribute to Takeda's mission by helping to build a better tomorrow for our patients and their families. 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 and Empower).
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).
Work within laboratory environment for extended periods of time, conducting analytical tests, reviewing analytical data, maintaining laboratory materials and instruments and other laboratory functions as required
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.
Complete mandatory training within required timeframe.
Perform other duties as assigned.
EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS:
Bachelor's or Master's Degree in any Life Sciences with relevant laboratory coursework.
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 managers and peers.
Must be able to read, write, and converse in English.
Must have basic computer skills. General use of word processing, spreadsheets, databases, etc. for the purposes of work execution, training, performance management, and self-service.
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.
In certain areas of Quality Control, the following may apply:
May be required to wear personal protective equipment (PPE) and other clean room garments daily. This may include: safety shoes, safety glasses, aprons, face shields, lab coats, full body gowns, hair nets and gloves and hearing protection.
May be required to participate in an on-call rotation for off-shift coverage or occasionally work off-shift hours to help support a 24-7 manufacturing department.
Willingness to travel to various meetings or training, this could include overnight trips.
Requires approximately 5% travel.
ADDITIONAL US SPECIFIC INFORMATION (FOR US RECRUITMENT ONLY):
Brooklyn Park, MN
Takeda Pharmaceutical Company Ltd