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Lab Assistant (Temporary)

Pharmacyclics, Inc.

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Location: Sunnyvale, CA Posted Date: 4/9/2013 Position Type: Temporary Job Code: 393 Required Education: Bachelors Degree

Description

Perform laboratory testing of intermediate product/starting materials, drug substance, and drug products for release and stability studies following Standard Operating Procedures (SOPs), and in compliance with cGMP regulations and guidelines.  Generate and record testing results accurately and document according to applicable regulatory and SOP requirements. Write and revise Standard Operating Procedures in compliance with cGMP regulations and corporate requirements.  Participate in method validation and method transfer activities.

Key Accountabilities/Core Job Responsibilities:
Perform QC release and stability testing of small molecule products according to SOPs and in compliance with cGMP regulations and guidelines
Deliver timely, accurate and reliable sample testing results following SOPs in a cGMP laboratory to support product development and release of preclinical and clinical materials.
Perform HPLC, GC, Dissolution, and Karl Fisher.
Maintain meticulous laboratory notebook documentation of testing.
Perform data analysis using application software, e.g. Waters Empower.
Qualifications: Pro-actively contribute to GMP laboratory compliance.
Maintain extensive knowledge of Standard Operating Procedures and GMP regulations and guidelines.

Requirements

Experience:
3+ years experience in analytical testing in the pharmaceutical industry, preferably in QC.
Working knowledge of GMPs, ICH, USP, and EMA highly desirable.
Experience with 21 CFR Part 11 validation projects a plus.
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