Quality Control Analyst

About AbbVie
AbbVie's mission is to discover and deliver innovative medicines 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, eye care, virology, women's health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com . Follow @abbvie on Twitter , Facebook , Instagram , YouTube and LinkedIn .

This position is responsible for the general use and application of technical standards, principles, theories, concepts and techniques. Under general supervision, the person in this position follows established procedures for all activities pertaining to WFI, Clean Steam and Environmental monitoring in the production area under cGMP standards. This role will assist in planning and be responsible for the execution of testing schedules (e.g. WFI, Clean Steam and EM) which contribute to the completion of milestones associated with specific projects and perform Bioburden, LAL and USP compendia tests on all water and clean steam samples. The person in this role will perform gram stain and other appropriate microbial identification functions as well as enumerate microbial count on environmental and water samples and perform growth promotion per USP on all media used. In addition, the QC Analyst is responsible for identifying and initiating deviations in any GMP operations (e.g. WFI, Clean Steam or Environmental monitoring) and revising controlled documents (e.g. SOP's and training plans) as needed.

Main Areas of Responsibility

• Manage all activities pertaining to WFI, Clean Steam, and Environmental monitoring in the production area under cGMP standards. Assist in planning and responsible for the execution of testing schedule (e.g. WFI, Clean Steam, and Environmental monitoring) which contributes to the completion of milestones associated with specific projects. Perform Bioburden, LAL and USP compendia tests on all water and clean steam samples.

• Perform gram stain and other appropriate microbial identification functions. Enumerate microbial count on environmental and water samples and perform growth promotion per USP on all media used.

• Responsible for some activities pertaining to LD50 assay such as, review LD50 data and enter test result data into BPA system, and ship test samples to contract lab as needed.

• Perform other duties as requested by management.

• Write and execute validation protocols for QC Microbiology equipments.

• Identify and initiate deviations related to GMP operations (e.g. WFI, Clean Steam of Environmental monitoring), revise SOPs as needed.

• Ensure the implementation of and adherence to procedures, to ensure the safety and health of personnel working within the QC Microbiology function. Ensure the implementation of and adherence to procedures and training to ensure the proper management of laboratory hazardous and biohazardous materials and wastes. Participate in internal EHS audits of QC Microbiology.

Qualifications

Education and Experience

• BS science degree, Minimum of 2 years experience in cGMP environment
• QC lab experience in biotech or pharmaceutical industry

Essential Skills and Abilities

• Proficient laboratory skills in order to perform Microbiology Tests
• Ability to handle a wide variety of tasks under time constraints.
• Ability to analyze data and summarize results.
• Ability to work in a Windows computer environment.
• Good document review skills including attention to detail and understanding of requirements.
• Computer skills to include Excel, Windows and Word.

Job Type
Standard

Schedule
Full-time

Equal Employment Opportunity
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.