Quality Control Analyst I - 2Nd Shift

Takeda Pharmaceutical Company Ltd Brooklyn Park , MN 55443

Posted 2 months ago

By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that I agree with Takeda's Privacy Notice, Privacy Policy and Terms of Use.

Job Description

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:

SHIFT:

  • 2:00pm to 10:30 pm Monday
  • Friday

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 and Empower).

  • Follow SOPs to perform methods requiring precise analytical skills and understanding of biology and chemistry principles.

ACCOUNTABILITIES:

  • 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.

LICENSES/CERTIFICATIONS:

  • NA

PHYSICAL DEMANDS:

  • Stand or sit -> Must be able to remain in a stationary or standing position for extended periods of time in both office and laboratory environment.

In certain areas of Quality Control, the following may apply:

  • Carry weight, lifting
  • Frequently moves laboratory materials and portable instruments weighing up to 30 pounds.
  • Climb
  • Occasionally ascends/descends step ladders to reach materials and/or stairs to collect samples.
  • Dexterity/balance - required to gown for cleanroom work, balance and dexterity are required.

OTHER REQUIREMENTS:

  • 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):

  • QC Analytical Skill Set
  • HPLC, Appearance, Concentration, pH, CE, Particulate Matter, Osmolality
  • QC BioAssay Skill Set
  • ELISAs, Cell Maintenance, Cell-Based Assays, Gels
  • QC Micro Skill Set
  • Endotoxin, Bioburden, Environmental Monitoring, Cleanrooms, Aseptic technique, Pharmaceutical water systems

Locations

Brooklyn Park, MN

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

icon no score

See how you match
to the job

Find your dream job anywhere
with the LiveCareer app.
Mobile App Icon
Download the
LiveCareer app and find
your dream job anywhere
App Store Icon Google Play Icon
lc_ad

Boost your job search productivity with our
free Chrome Extension!

lc_apply_tool GET EXTENSION

Similar Jobs

Want to see jobs matched to your resume? Upload One Now! Remove
Manufacturing Team Member II 2Nd Shift Molding

Integer

Posted 2 months ago

VIEW JOBS 10/15/2020 12:00:00 AM 2021-01-13T00:00 At Integer, our vision and values are embedded in everything we do! If you want to work for an organization that values customer focus, teamwork, respect, integrity, communication and innovation, apply now! * Adheres to Integer Values and all safety, environmental, security and quality requirements including, but not limited to: Quality Management Systems (QMS), Safety, Environmental and Security Management Systems, U.S. Food and Drug Administration (FDA) regulations, company policies and operating procedures, and other regulatory requirements. * Sets up equipment needed for assembly/inspection as per Manufacturing Process Instructions (MPI's) and Quality Work Instructions (QWI's). * Understands own tasks and how they relate to others in their team. Works under moderate Supervision where duties are clearly defined. Will follow Standard Work where applicable. * Understands overall production flow within their department. * Assembles component parts as per print. Utilizes both manual and automatic machine operation. * Visually and/or dimensionally inspects parts and/or completed assemblies for conformance to specifications. Identifies and escalates quality non-conformances. * Completes required Device History Records and other manufacturing documentation per Good Documentation Practices (GDP) * May package assemblies for shipping. * Participates in team activities focusing on process/product improvement, problem resolution, and customer satisfaction. * Maintains safe and clean working environment by complying with procedures, rules, and regulations * Actively participates in "flex break" programs as required. * Expands skill base through on the job training, cross training and classroom instruction. * Performs other functions as required. Minimum Education: * High school graduate or equivalent. Minimum Experience: * 1 year of Integer related work experience and/or 2-4 years light assembly experience in a regulated industry required; medical device experience preferred. Specialized Knowledge: * Ability to read, comprehend and follow detailed instruction. Must possess the ability to recognize defects in workmanship. Demonstrate competency in assembly processes. Special Skills: * Ability to read blueprints preferred. Familiarity with microscopes and measuring devices preferred. Previous light assembly experience in a regulated industry with Medical devices preferred. Certification for industry specific assembly requirements such as IPC soldering standards for the Medical device and Military markets. Other: * Proficient in assembly operations. Work is closely supervised. Integer Brooklyn Park MN

Quality Control Analyst I - 2Nd Shift

Takeda Pharmaceutical Company Ltd