Quality Control Analyst
1 week ago
At one of our 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 I at our Los Angeles, CA site. Here, you will be a vital contributor to our inspiring, bold mission.
Summary:
Under supervision, the Microbiology 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. Support with various QC Micro activities including, EM sampling, plate reads, water collection, testing, and assisting with lab investigations. Conducts and able to perform a wide range of biological, chemical and physical analyses on pharmaceutical products (biologics and drugs) and medical devices through all stages of the manufacturing process from incoming raw materials to finished goods, and may include environmental monitoring programs.
Title: Quality Control Analyst I
Department: QC Microbiology
Location: Glendale, CA - Onsite
Duration: 6-12 months Temp w/ potential for extension or conversion
Day Shift: Mon-Fri 6AM-2:30{\PM
Description:
Responsible for performing environmental monitoring of clean rooms and controlled areas to support qualifications and routine sampling of the facility and critical utilities including WFI, compressed gas, nitrogen, etc. Conduct microbial-based assays including bioburden testing, microbial quantification, and organism identification. Additional testing includes LAL, pH, TOC, and Conductivity.
Additional Responsibilities:
Takeda is searching for a highly motivated Contract QC Microbiologist who will be responsible for routine EM, water collection, compressed gas collection and compendial testing of microbiology laboratory methods (LAL, TOC, Conductivity, Bioburden).
Must Haves:
- GMP experience in biotech and/or pharma industry
- 1+ years of QC Microbiology experience is a must/Bachelor's Science Degree
- Strong knowledge of regulatory guidance and industry practices
- Knowledge and experience in Environmental monitoring microbiological methods, clean room and contamination control, .
- Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities.
- Micro experience: environmental monitoring, water collection/testing, LAL, Compressed Gas sampling, plate reading, growth promotion, etc.
- Endotoxin Testing, Bioburden testing, and/or TOC/Conductivity testing
Soft Skills:
- Communication
- Solid team player, able to meet deadlines and changing priorities.
- Problem Solving
- Initiative
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