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POSITION SUMMARY: 

The QC Analyst II is responsible for conducting routine analysis of the NHPRR reagents. Compiles data for documentation of test procedures and prepares reports. Calibrates and maintains lab equipment. May develop testing methods independently or under the supervision of Sr. QC Analyst. Reviews data obtained for compliance with specifications and reports abnormalities. Applies knowledge of Good Manufacturing Practices or Good Laboratory Practices daily.

ESSENTIAL FUNCTIONS:

• Performs assays as detailed in the respective SOPs.
• Interprets test results against acceptance criteria and determines if the assay results pass or fail.
• Maintains proper documentation of all QC lab work performed in benching.
• Supports any QC laboratory investigations under the guidance of the Team Leader or Senior QC Analyst.
• Provides support in developing and qualifying new test methods under the supervision of the team leas or Senior QC Analyst.
• Is responsible for peer review of QC data.
• Updates QC SOPs as directed by the Team Leader or Senior QC Analyst.
• Is responsible for routine preventive maintenance, general troubleshooting, general cleanliness, and calibration of lab equipment.
• Maintains products and samples by following the established procedures.
• Performs any other duties as directed by the Team Leader or Senior QC Analyst.
• Should be able to complete all assigned tasks and Self-assign work without immediate supervision when appropriate.
• Maintains the laboratory and ensures that it is continuously kept in a safe and orderly condition.
• Provides approved documents to clients as needed.
• Should be able to take direction and correction when learning new procedures and analyses.

REQUIRED QUALIFICATIONS:

• Requires a bachelors degree in pharmacy, chemistry or a related field with 3+ years of relevant experience, or a masters degree in chemistry or a related field with 1+ years of relevant experience, or a Ph.D. with 0-2 years of relevant experience.
• Prior experience in GMP or GLP laboratory for at least one year.
• Familiar with FDA, USP and ICH guidelines.
• Good analytical skills with ability to understand and analyze data.
• Good time management skills with the ability to ensure accurate and timely data reports.
• Good verbal, written, and interpersonal communication as well as organizational skills.