Senior Quality Control Analyst

4 weeks ago

Thousand Oaks, United States Randstad Full time

At a top Pharmaceutical companies, 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.


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 III at our Thousand Oaks, CA site. Here, you will be a vital contributor to our inspiring, bold mission.


Summary:

With minimal supervision, the Quality Control Analyst III in the QC Microbiology department will conduct biological or chemical analyses on raw materials, in-process samples, final product samples or samples collected from environmental monitoring programs at Takeda manufacturing facilities.


Title: Quality Control Analyst III

Location: Fully Onsite Thousand Oaks, CA

Shift: 4day 10 hour work weeks

Pay: $40-$50/hr. (depending on experience)

Duration: 6 months to start


Responsibilities:

  • Use laboratory instrumentation and analytical equipment to test samples. Use computer systems (LIMS) to collect and record data.
  • Maintain data integrity and ensure compliance with company SOPs and specifications, FDA, GLP, QSR and cGMP regulations.
  • Perform review of test data, which includes overall documentation practices (CGDP). Perform release functions in LIMS or other computerized systems.
  • May prepare monthly quality trend reports.
  • Maintain test equipment, equipment maintenance and calibrations as required.
  • Assist or initiate special projects / protocol testing that involves new methods and instrumentation and oversee testing activities.
  • Lead or participate in functions involving teams, which impact production, increase efficiency, solve problems, generate cost savings, and improve quality.
  • Apply advanced laboratory skills to perform complex assays requiring precise analytical skills and understanding of microbiology and chemistry principles.
  • Investigate complex nonconformance and write exception documents or lead others in writing investigation.
  • Handle multiple tasks concurrently including testing, special project/protocol testing in a timely and appropriate manner.
  • Perform final approval of exception documents, test data, and release functions in LMS or other computerized systems.
  • Perform laboratory and manufacturing audits as required. Audit and update, as required, plant SOPs.
  • Provide training, explain process and provide work direction for QCA II’s or QCA I’s on complex processes as required.
  • A technical expert for their specific part of the process.
  • Troubleshoot and resolve process related issues or assay and instrument problems.
  • Write and execute validations for manufacturing processes and laboratory instruments and methods.
  • Write detailed investigation reports that consistently meet the requirements of the Takeda Quality Organization and the expectations of regulatory agencies.
  • Prioritize multiple projects/workflows and manage time efficiently to meet established timelines.
  • Complete tasks with minimal direction from lead and/or supervisor.
  • Demonstrate effectiveness in ability to train others, drive results, and meet deadlines.


Qualifications:

  • 3+ years' experience in advanced wet and instrumental methods of analyses.
  • 3+ years' experience of change control practices for major equipment, critical systems, instrumentation, and computerized systems.
  • Knowledge of quality systems including exception management, change control, document control, etc.
  • Knowledge of how to implement investigation strategies and apply root cause failure analysis.
  • Proficient in laboratory functions, test methods, equipment (including but not limited to analytical equipment, autoclaves, incubators, and environmental monitoring equipment), processes and applicable procedures.
  • Knowledge of FDA regulations, application of Good Laboratory Practices, Good Manufacturing Practices, Good Documentation Practices.
  • Knowledge Laboratory safety including standard precautions and hazardous and biohazardous chemical handling.
  • 2+ years' experience Change control practices for major equipment, critical systems, instrumentation, and computerized systems.
  • Quality systems including exception management, change control, document control, etc.
  • Operating and troubleshooting procedures for lab equipment, and quality and regulatory requirements pertinent to pharmaceutical and medical device manufacturing labs.
  • Knowledge of how to implement investigation strategies and apply root cause failure analysis.
  • Solid team player, able to meet deadlines and changing priorities.
  • Able to communicate effectively with peers, co-workers, and leadership team.
  • Very detail oriented and able to produce high quality work.
  • Strong interpersonal skills and be able to work effectively and efficiently in a team environment.
  • Strong decision-making skills, strong technical problem-solving ability, and analytical skills.
  • Proficient in a variety of mathematical disciplines. Ability to use and apply statistical tools a plus.
  • Proficiency with the MS Office suite of programs (including Microsoft Word, Excel, and, PowerPoint).


Must Haves:

  • Bachelor’s Degree in Microbiology or Biological Sciences (with Microbiology Laboratory) is strongly preferred.
  • Minimum 3 years of related work experience.
  • Experience in quality operations, biotechnology, pharmaceutical or similar GMP manufacturing environment is strongly preferred.

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