Quality Control Analyst

Location: Santa Monica, CA

Duration: 12 months with possibility of extension

Pay: $32.55 per hour

The QC Analyst will play a crucial role in Quality Control Operations including sample management, equipment management and execution of established compendial methods in the AstraZeneca Quality Control Laboratory. This position is essential for ensuring that the laboratory meets the high standards required for CGMP Quality Control Operations.

Qualifications:

• Bachelor's degree preferably in Biology or equivalent with 1-2 years of relevant CGMP laboratory experience; OR Associate's degree preferably in Biology or equivalent with 2-3 years of relevant CGMP laboratory experience
• Strong experience with receipt, storage, inventory, and distribution of samples for analytical testing.
• 1-2 years executing routine and non-routine analysis for CGMP compendial assays (Appearance, pH, etc.)
• Experience in customer service and strong communication skills.
• Familiar with basic computer applications such as Microsoft Outlook, Word and Excel
• Experience with labeling and distribution of reagents, controls and reference standards.
• Experience operating and maintaining Temperature-Controlled Storage Units.
• The ideal candidate will possess excellent attention to detail, strong communication skills, and the ability to analyze raw data effectively.
• Ability to support two AstraZeneca sites for Quality Control Operations as needed is preferred.

Responsibilities:

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

•    The candidate will also be responsible for the operation, organization and maintenance of Temperature-Controlled Storage Units and ensure that samples, reagents, standards and controls are stored in appropriate temperature conditions utilizing paper and computer-based asset systems.

•    Document activities, records observations and completes all paperwork in accordance with CGMPs, SOPs, and protocols. The candidate will complete and document activities following established site-specific documents, as applicable.

•    Perform compendial assays and qualification of critical reagents methodologies.

•    Execute tech transfer, qualification, and validation protocols as needed.

•    Contribute to writing and revising Standard Operating Procedures (SOPs) and other Good Manufacturing Practices (GMP) documentation as appropriate.

•    Report invalid/out-of-specification results to QC management

•    This position is essential for ensuring that the laboratory meets the high standards required for GMP release and stability testing

•    The role also involves contributing to the writing and revision of Standard Operating Procedures (SOPs) and other CGMP documentation, supporting the management of test samples, reagents, and reference standards, and reporting any invalid or out-of-specification results to the QC Departmental management

•    The position requires a strong background in laboratory practices, general testing methodology, assay troubleshooting, and familiarity with Quality Systems

•    Execute tech transfer, qualification, and validation protocols as needed

•    Perform other duties as assigned.

•    Ability to follow safety procedures outlined in the Safety Health and Environmental safety