Associate, Quality Control Analytical
About The Position
AstraZeneca is seeking an energetic and experienced individual with cell therapy quality control background to join our Quality Control (QC) 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: Monday to Friday, 5X8, 9AM-5:30PM 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 computerised 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.
Requirements
- Associate's degree preferably in Biology or equivalent with 2-3 years of relevant CGMP laboratory experience
- Strong experience with 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.
Nice To Haves
- Experience in Cell &/or Gene Therapy
- Bachelor's degree preferably in Biology or equivalent with 1-2 years of relevant CGMP laboratory experience.
Responsibilities
- receipt, storage, inventory, and distribution and preparation of samples, controls, reagents and standards used in analytical testing, utilizing paper and computer-based inventory systems.
- 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.
- support the calibration and maintenance activities required for QC equipment using computerised 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.
- contributing to the writing and revision of Standard Operating Procedures (SOPs) and other CGMP documentation.
- Perform other duties as assigned.
- Ability to follow safety procedures outlined in the Safety, Health and Environmental requirements.
Benefits
- eligibility to participate in our equity-based long-term incentive program.
- Benefits offered included a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Education Level
Associate degree
