Quality Control Analyst

2 days ago

Thousand Oaks, United States Randstad Full time

At a top Biopharmaceutical company, 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 at our Thousand Oaks, CA site. Here, you will be a vital contributor to our inspiring, bold mission.


Summary:

The QC Analyst is responsible for conducting biological or chemical and physical analyses on raw materials, in-process samples, final product samples and other samples collected from manufacturing areas.


Title: Quality Control Analyst I/II

Department: Analytical Quality Control

Location: Thousand Oaks, CA - Fully Onsite

Pay: Dependent on Experience/Level

Duration: 6 months w/ potential for extension


Additional Responsibilities:

  • Apply laboratory skills to perform complex assays requiring precise analytical skills and understanding of analytical and chemistry principles.
  • Wet Chemistry, knowledge, skills, and expertise in performing chemical experiments that involve the use of liquids, or "wet" chemicals. This can include tasks such as preparing chemical solutions, conducting chemical reactions, and analyzing chemical compounds using various wet chemical techniques such as titrations, extractions, filtrations, and precipitation.
  • Raw Materials, Product Release, and Stability Monitoring Testing (Routing and on-demand)
  • Ordering, Troubleshooting, Service Catalog Ordering, Schedule Repairs and Preventive Maintenance of HPLC/Raw Material Instruments
  • Perform review of test data, which includes overall documentation practices (CGDP). Perform release functions in LIMS or other computerized systems.
  • Maintain data integrity and ensure compliance with company SOPs and specifications, FDA, GLP, QSR, and CGMP regulations.
  • Investigate complex nonconformances and write exception documents
  • Column/Control/Standard Qualification for release testing


Qualifications:

  • Bachelor’s Degree in Chemistry, Microbiology or Biological Sciences strongly preferred. With 1+ years' industry experience (Recent grads are encouraged to apply w/ lab experience)
  • Experience with HPLC testing, analytical chemistry testing

General understanding & knowledge of the following:

  • Lab Functions, test methods, equipment (including analytical equipment, autoclaves, incubators, and environmental monitoring equipment)
  • Wet and instrumental methods of analyses
  • Operating and troubleshooting procedures for lab equipment
  • HPLC Testing, Raw Material, Elisa (preferred), LIMs
  • Ability to write detailed investigation reports, knowledge of how to implement investigation strategies and apply root cause analysis failure analysis is a plus
  • Knowledge of FDA regulations, application of Good Laboratory Practices (GLP), application of Good Manufacturing Practices (GMP) and application of Good Documentation Practices (GDP)
  • Knowledge of quality and regulatory requirements pertinent to pharmaceutical manufacturing labs is a plus

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