Job Title Quality CONTROL Analyst I (QC Analytical)

Department Quality and Compliance

Reports to Supervisor or Manager, Quality Control

DESCRIPTION

Position Overview

The Quality Control Analyst I performs routine laboratory activities in support of Good Manufacturing Practices (GMP) testing for Quality Control (QC). Testing includes qPCR, immunostaining, protein characterization and product specific analytical test methods. Interacts with employees internal and external to Quality Control.

Essential Duties and Responsibilities

• Works on QC tasks of diverse scope, requiring basic knowledge of laboratory concepts.

• Train on applicable Standard Operating Procedures (SOPs) and Methods.

• Perform in-process and finished drug product analysis, using standard techniques in biochemistry, molecular biology and cell biology, and according to approved test methods.

• Completes laboratory work with precision, and maintains hardcopy paperwork and electronic data in organized manner, in compliance with company documentation practices (GDP).

• Provides input to improving QC systems and procedures to improve GMP compliance.

• Proactively communicates laboratory issues to supervisor or manager. Initiates laboratory investigations related to test failures, discrepancies and deviations.

• Helps maintain the laboratories in a GMP compliant state, including participating in cleaning, instrument routine and preventative maintenance, logbook usage and review, etc.

• Performs other duties as assigned by management.

  Qualifications

   

• BS in biochemistry, biology, microbiology, molecular biology or other relevant discipline with 1 to 3 years of relevant experience.

• Experience and knowledge in the pharmaceutical and/or biotech industry within a GMP and/or GLP environments preferred.

• Experience in cell culture, qPCR and protein analysis preferred.

• Understanding of basic scientific concepts in one or more areas above.

• Experience with relevant analytical lab equipment and computers preferred.

• Good mathematical and organizational skills

• Ability to interact constructively with co-workers to solve problems and complete tasks

• Some weekend work or late nights may be required periodically.

  Physical Demands

  A normal range of hearing and vision correctable to 20/20, and Occasional lifting up to 25 pounds is required.

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