Quality Control Laboratory Specialist

Position Summary

The candidate will be primarily responsible for the receipt, storage, inventory, and distribution and preparation of samples, controls, reagents and standards used in analytical testing, utilizing paper and computer-based inventory systems.

Responsibilities

• Operate, organize and maintain Temperature-Controlled Storage Units and ensure samples, reagents, standards and controls are stored in appropriate temperature conditions utilizing paper and computer-based asset systems.
• Support the calibration and maintenance activities required for QC equipment using computerized asset management software.
• Complete and document activities in accordance with CGMPs, SOPs, and protocols.
• Perform compendial assays and processing of samples as needed.
• Report deviation events to QC management.
• Contribute to the writing and revision of Standard Operating Procedures (SOPs) and other CGMP documentation.

Qualifications

• Achieve Associate's degree preferably in Biology or equivalent with 2-3 years of relevant CGMP laboratory experience.
• Show strong experience with good documentation practices, receipt, storage, inventory control, and distribution of samples and reagents for analytical testing.
• Show 1-2 years executing routine and non-routine analysis for CGMP compendial assays (Appearance, pH, etc.).
• Show experience in Customer Service and Strong Communication Skills.
• Show familiarity with basic computer applications such as Microsoft Outlook, Word and Excel.
• Show experience with labeling and preparation of reagents, controls and reference standards.
• Show experience operating and maintaining Temperature-Controlled Storage Units, including cryogenic (LN2) freezers.