Supervisor I, QC Lab

About the Company

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 including immunology, oncology and neuroscience — and products and services in our Allergan Aesthetics portfolio.

About the Role

The QC Lab Supervisor I is responsible for the organization, administration, and supervision of Lab Analysts and other Lab employees; properly overseeing the day-to-day operations by prioritizing shop floor presence and receiving guidance and direction from more senior leaders. Oversees the processes of the chemical analysis and release of raw materials, in-process, and final products in compliance with current quality criteria while respecting deadlines and managing costs. Ensures effective and efficient utilization of laboratory resources through management of laboratory support activities.

Responsibilities

• Lead and develop a high-performing team while prioritizing shop floor presence, including hiring, setting performance expectations, providing continuous and on-time performance feedback, coaching staff, assisting in problem-solving, and handling employee matters.
• Ensure the department has the appropriate talent and level of performance to meet business objectives.
• Monitor administration of training, identify training needs, and ensure development of the team.
• Oversee the operation and functions of the laboratory group, which may include Raw Materials, Finished Products, Projects/validation samples, MEC, and stability samples.
• Organize laboratory activity by coordinating personnel depending on planning demands.
• Control products (raw materials, intermediates, and finished products) by following procedures to meet the lab testing schedule.
• Identify aspects of tests or results warranting further attention and implement corrective actions.
• Review and approve analytical data (may relate to analytical product release depending on regional regulatory requirements).
• Support laboratory investigations, including out-of-specification test results, and ensure effective corrective actions are implemented.
• Effectively understand, communicate, and present QC Metrics; attend and lead Tier meetings.
• Ensure appropriate procedures are in place and QC activities are executed in line with internal procedures, cGMP requirements, and relevant safety standards.
• Assist in implementing continuous improvement actions to lab processes.
• Assist analysts with analytical/microbial instrumentation and ensure instrumentation availability to achieve schedule.
• Improve capacity by ensuring preventive and repair maintenance, as well as material qualifications, are carried out in a timely manner.
• Plan instrument needs by maintaining permanent technical and technological intelligence.
• Apply systematic corrections and/or corrective actions to mitigate the risk of recurrent instrumentation failures.
• Assist in the periodic inspection of laboratory facilities to ensure compliance with Good Manufacturing Practices (GMP) and Good Laboratory Practices, maintaining laboratory audit readiness.
• Support supplier, internal, and regulatory audits when required.
• Serve as a backup when the Lab Manager is unavailable.
• Generate and manage non-hazardous and hazardous waste in accordance with internal operating procedures and compliance with local and federal regulations.

Qualifications

• Bachelor’s degree required, preferably in a scientific field (Chemistry, Microbiology, or Biology).
• 2+ years of QC Lab experience required.
• Demonstrated thorough scientific knowledge and technical expertise in chemistry, technical writing, investigations, analytical laboratory equipment, and laboratory operations.
• General knowledge of cGMPs, compendia, and regulations required.
• Effective problem-solving, decision-making, teamwork, influence, negotiation, and conflict resolution skills.
• Ability to foster an inclusive environment.
• Ability to work cross-functionally and coordinate work both within the department and with other departments.
• Ability to interpret the impact of laboratory data for appropriate and effective actions.
• Ability to identify, develop, communicate, and follow through to completion necessary corrective action plans to resolve problems.

Benefits

• Comprehensive package of benefits including paid time off (vacation, holidays, sick).
• Medical, dental, and vision insurance.
• 401(k) eligibility.
• Eligibility to participate in short-term incentive programs.