Senior Analyst, Laboratory Quality Control

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 . 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. 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

• 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.

Nice To Haves

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

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.
• 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.
• 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
• Education Level: Associate degree