Quality Laboratory Analyst

AbbVie • Irvine, CA

1d

About The Position

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com . Follow @abbvie on X , Facebook , Instagram , YouTube , LinkedIn and Tik Tok . Coordinates and supports laboratory testing, product disposition including documentation and justification of nonconforming events, method validations, and prepares Laboratory/Validation reports. Requires knowledge and technical expertise of Microbiology, regulatory requirements and Global TrackWise system. 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.

Requirements

• 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.
• Advanced Microsoft Office and SAP user experience preferred.
• Knowledge of LIMS and Trackwise preferred
• 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 preferred.
• Audit experience preferred.

Nice To Haves

• Knowledge in general microbiology preferred (Gram-stain, spore stain, streaking, growth promotion…).

Responsibilities

• Coordinates and supports laboratory testing, product disposition including documentation and justification of nonconforming events, method validations, and prepares Laboratory/Validation reports.
• Requires knowledge and technical expertise of Microbiology, regulatory requirements and Global TrackWise system.
• 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.
• 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.
• Conduct all work activities in compliance with AbbVie internal and applicable regulatory requirements.

Benefits

• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
• This job is eligible to participate in our short-term incentive programs.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level