Quality Control Analyst

KellyOCG; Los Angeles (CA); On-site; USD 36,000 - 52,000; Full time

Job summary

AstraZeneca is seeking a QC Operations professional to support sample and reagent management, inventory control, and CGMP documentation in the Quality Control Laboratory. The role focuses on ensuring proper conditions for temperature-controlled storage and rigorous record-keeping.

The candidate will participate in calibration and maintenance of QC equipment, perform CGMP-conformant documentation, and contribute to SOP writing. Strong attention to detail and communication are essential.

Qualifications

• Associate's degree in Biology or equivalent with 2–3 years CGMP lab experience.

Responsibilities

• Receipt, storage, inventory, distribution and preparation of samples, controls, reagents and standards used in analytical testing.

Skills

Communication skills

Documentation practices

Inventory management

Analytical testing

Team collaboration

Education

Associate degree in Biology or equivalent

Bachelor's degree in Biology or related field (preferred)

Tools

Microsoft Outlook

Microsoft Word

Microsoft Excel

Inventory software

Job description

Duration: 12 months w/possibility of extension

Pay: $31.92

Position Summary:

AstraZeneca is seeking an energetic and experienced individual with cell therapy quality control background to join our Quality Control (QC) Operations team. The successful candidate will contribute to the advancement of our product pipeline by playing a crucial role in Quality Control Operations including sample management, equipment management and reagent management 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.

This position operates on the following shift, and is subject to change:

• Friday - Monday; 12:00PM to 10:00pm (4/10 shifts)

Responsibilities:

• 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.
• 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.
• The candidate will support the calibration and maintenance activities required for QC equipment using computerized asset management software
• The candidate will 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.
• This position is essential for ensuring that the laboratory meets the high standards required for CGMP lot release and stability testing
• The role also involves contributing to the writing and revision of Standard Operating Procedures (SOPs) and other CGMP documentation.
• The position requires a strong background in laboratory practices, general testing methodology, assay troubleshooting, and familiarity with Quality Systems.
• Perform other duties as assigned.
• Ability to follow safety procedures outlined in the Safety, Health and Environmental requirements.
• Routine lifting of cryogenic racks weighing up to 25 pounds.

Qualifications:

• Associate's degree preferably in Biology or equivalent with 2-3 years of relevant CGMP laboratory experience
• Strong experience with good documentation practices, receipt, storage, inventory control, and distribution of samples and reagents 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 preparation of reagents, controls and reference standards.
• Experience operating and maintaining Temperature-Controlled Storage Units, including cryogenic (LN2) freezers.
• The ideal candidate will possess excellent attention to detail, strong communication skills, and the ability to analyze raw data effectively.

Preferred Qualifications:

• Experience in Cell &/or Gene Therapy
• Bachelor's degree preferably in Biology or equivalent with 1-2 years of relevant CGMP laboratory experience.