AbbVie · 15 hours ago
Quality Laboratory Analyst
Irvine, CA
Full-time
Onsite
Mid Level
$64K/yr - $122K/yr
3+ years expAbbVie is dedicated to discovering and delivering innovative medicines and solutions for serious health issues. The Quality Laboratory Analyst role involves coordinating and supporting laboratory testing, ensuring compliance with regulations, and maintaining laboratory data integrity.
BiotechnologyFinancial ServicesHealth CareMedicalPharmaceuticalVenture Capital
No H1B
Security Clearance RequiredU.S. Citizen Only
Responsibilities
Coordinates and supports laboratory testing, product disposition including documentation and justification of nonconforming events, method validations, and prepares Laboratory/Validation reports
Understand Regulations and business processes required to maintain Laboratory Data Integrity
Maintain and comply with Laboratory Documentation and Computerized Systems Data Integrity requirements
Adhere to cGMP requirements
Adhere to and supports all EHS & E standards, procedures and policies
Responsible for the timely completion of assigned laboratory testing
Ensure that all test equipment is used and maintained correctly
Able to work independently under minimal supervision
Perform environmental monitoring in cleanrooms within the manufacturing area
Collect water samples throughout the manufacturing facility and test for bioburden and endotoxin
Perform bioburden and endotoxin for final drug substance
Knowledge in general microbiology preferred (Gram-stain, spore stain, streaking, growth promotion…)
Able to work in an environment where respirator is required to be worn during production for at least 4 hours
Position requires constant body movement such as lifting, carrying equipment during environmental monitoring, pushing carts, doors
Able to accommodate weekend and holiday work as required by the manufacturing schedule
Able to take ownership and update procedures to meet current cGMP requirements
Participate in method transfers and validations as needed
Responsible for daily activities such as waste disposal, glasswashers, autoclave runs
Able to maintain accurate inventory records of toxin during usage
Furthermore, the position requires the individual to work with and in areas requiring select agents (i.e. Biosafety level 2 and biosafety level 3 laboratories). Access to and use of select agents is regulated by federal policies. Therefore, the candidate must conduct all work activities in compliance with AbbVie internal and applicable regulatory requirements
Qualification
Required
Bachelor's Degree in Microbiology or related Biological Sciences, with a minimum of three (3) years of lab experience
Two (2) years of experience in Industrial Microbiology with an emphasis in the Pharmaceutical and/or Medical Device industry, or equivalent experience
Knowledge of microbiology and regulatory requirements
Advanced Microsoft Office and SAP user experience
Experience in the manufacture of pharmaceuticals with knowledge of water systems, clean rooms, and aseptic filling and process validation
Experience working in a GMP regulated environment
Ability to understand Regulations and business processes required to maintain Laboratory Data Integrity
Ability to maintain and comply with Laboratory Documentation and Computerized Systems Data Integrity requirements
Ability to adhere to cGMP requirements
Ability to adhere to and support all EHS & E standards, procedures and policies
Ability to complete assigned laboratory testing in a timely manner
Ability to ensure that all test equipment is used and maintained correctly
Ability to work independently under minimal supervision
Ability to perform environmental monitoring in cleanrooms within the manufacturing area
Ability to collect water samples throughout the manufacturing facility and test for bioburden and endotoxin
Ability to perform bioburden and endotoxin for final drug substance
Ability to work in an environment where respirator is required to be worn during production for at least 4 hours
Ability to accommodate weekend and holiday work as required by the manufacturing schedule
Ability to take ownership and update procedures to meet current cGMP requirements
Ability to participate in method transfers and validations as needed
Ability to maintain accurate inventory records of toxin during usage
Ability to work with and in areas requiring select agents (i.e. Biosafety level 2 and biosafety level 3 laboratories)
Ability to conduct all work activities in compliance with AbbVie internal and applicable regulatory requirements
Preferred
Knowledge in general microbiology (Gram-stain, spore stain, streaking, growth promotion…)
Knowledge of LIMS and Trackwise
Experience working in a GMP regulated environment
Audit experience
Benefits
Paid time off (vacation, holidays, sick)
Medical/dental/vision insurance
401(k)
Short-term incentive programs
Company
AbbVie
AbbVie is a biopharmaceutical company focused on immunology, oncology, neuroscience, virology, and aesthetics. It is a sub-organization of AbbVie.
10001+ employees
Funding
Current Stage
Public CompanyTotal Funding
$15B2024-02-27Post Ipo Debt· $15B
2023-03-08Post Ipo Equity· $0.25M
2012-12-20IPO
Leadership Team
Robert Michael
Chairman of the Board and Chief Executive Officer
Micah Bregman
Vice President, Global Strategy and Pipeline, Allergan Aesthetics
Recent News
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2025-12-29
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2025-12-27
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