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Allergan Aesthetics, an AbbVie Company · 14 hours ago

Senior Analyst, Laboratory Quality Control

Irvine, CA

Full-time

Onsite

Mid, Senior Level

$73K/yr - $138K/yr

3+ years exp

Allergan Aesthetics, an AbbVie Company, is focused on delivering innovative medicines and solutions in the pharmaceuticals industry. The Senior Analyst in Laboratory Quality Control will perform quality laboratory testing for the manufacturing process, ensuring compliance with regulations and maintaining laboratory data integrity.

BeautyManufacturingPharmaceuticalWellness

No H1B

Security Clearance Required

U.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

Microbial testingAnalytical testingHPLCLaboratory techniquesLaboratory instrumentsComputerized systemsVerbal communicationWritten communication

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