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Allergan Aesthetics, an AbbVie Company · 15 hours ago

Quality Laboratory Analyst

Irvine, CA

Full-time

Onsite

Mid Level

$64K/yr - $122K/yr

3+ years exp

AbbVie is a company dedicated to discovering and delivering innovative medicines and solutions. They are seeking a Quality Laboratory Analyst to coordinate and support laboratory testing, product disposition, and method validations while ensuring compliance with regulations and data integrity requirements.

BeautyManufacturingPharmaceuticalWellness

No H1B

Security Clearance Required

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. Employment is contingent upon CDC and FBI clearance

Qualification

MicrobiologyGMP regulationsLaboratory DocumentationSAPLIMSTrackwiseEnvironmental monitoringAseptic fillingAudit experienceSoft skills

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 preferred