AbbVie · 1 day ago
Senior Analyst, Laboratory Quality Control
Irvine, CA
Full-time
Onsite
Mid, Senior Level
3+ years expAbbVie is a company dedicated to discovering and delivering innovative medicines and solutions to address serious health issues. The Senior Analyst in Laboratory Quality Control is responsible for performing quality laboratory testing for manufacturing processes and ensuring compliance with laboratory data integrity and cGMP requirements.
BiotechnologyFinancial ServicesHealth CareMedicalPharmaceuticalVenture Capital
No H1B
Security Clearance RequiredU.S. Citizen Only
Responsibilities
Performs quality laboratory testing required for the manufacturing process, utilities, raw materials, in process samples and final product following specifications in both the microbiological and analytical laboratories
Performs microbiological and analytical testing such as bio burden, endotoxin, TOC, pH and conductivity to water samples used in the product manufacturing process and to the final product
Performs in process product testing such as bio burden, and endotoxin and analytical testing (HPLC, Gel Electrophoresis, DNA), among others
Performs other microbiological lab testing such as growth promotion and identification of microorganisms
Provides support in method transfer, equipment/instrument qualification and process validation
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
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
Participate in method transfers and validations as needed
Authoring and review of documents such as protocols, reports, test methods, SOPs
Owning and supporting cGMP routine testing by owning quality system records required for deviations, laboratory investigations, CAPAs and out – of -specification (OOS) results
Support the qualifications of new laboratory equipment
Responsible for daily activities such as waste disposal, glasswasher, autoclave runs
Able to maintain accurate inventory records of toxin during usage
Qualification
Required
Associate degree in science (major in Biology, Chemistry, Microbiology or Medical Technology) and five (5) years of relevant laboratory experience; or bachelor's degree in science (major in Biology, Microbiology or Chemistry), and three (3) years of relevant laboratory experience
Experience in the general microbial and analytical testing/methodology (e. g. endotoxin, bio burden, HPLC, Gel Electrophoresis)
Basic knowledge of laboratory techniques and laboratory instruments
Basic knowledge of computerized systems
Basic verbal and written communication skills in English
Preferred
Knowledge in general microbiology preferred (Gram-stain, spore stain, streaking, growth promotion…)
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
2026-01-23
2026-01-20
2026-01-20
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