QC Lab Supervisor I

AbbVie • North Chicago, IL

2d

About The Position

The QC Lab Supervisor I organizes, administers, and supervises Lab Analysts and other laboratory employees. The role oversees day-to-day laboratory operations, with an emphasis on shop-floor presence, and receives guidance and direction from more senior leaders. It oversees chemical analysis and release of raw materials, in-process materials, and final products in accordance with current quality criteria, deadlines, and cost expectations. The supervisor also ensures effective and efficient use of laboratory resources through management of laboratory support activities.

The position leads and develops the laboratory team; coordinates testing activities; oversees laboratory functions and analytical data review; supports investigations and corrective actions; and helps maintain compliance with internal procedures, cGMP, safety standards, GMP, and Good Laboratory Practices. It also supports laboratory instrumentation availability, continuous improvement, audit readiness, and waste management. The supervisor may serve as backup for the Lab Manager when needed.

Requirements

• Bachelor’s degree required.
• At least 2 years of QC laboratory experience required.
• Thorough scientific knowledge and technical expertise in chemistry, technical writing, investigations, analytical laboratory equipment, and laboratory operations required.
• General knowledge of cGMPs, compendia, and regulations required.
• Effective problem-solving, decision-making, teamwork, influence, negotiation, and conflict-resolution skills required.
• Ability to foster an inclusive environment.
• Ability to work cross-functionally and coordinate work within the department and with other departments.
• Ability to interpret laboratory data and its impact to determine appropriate and effective actions.
• Ability to identify, develop, communicate, and follow through on corrective action plans to resolve problems.

Nice To Haves

• A scientific field of study, preferably Chemistry, Microbiology, or Biology.

Responsibilities

• Lead and develop a high-performing team, including hiring, setting performance expectations, providing timely feedback, coaching, assisting with problem-solving, and handling employee matters.
• Ensure the department has the talent and performance needed to meet business objectives; monitor training administration, identify training needs, and support team development.
• Oversee laboratory group operations, which may include Raw Materials, Finished Products, Projects/validation samples, MEC, and stability samples.
• Coordinate personnel and laboratory activities according to planning demands and testing schedules.
• Oversee testing and control of raw materials, intermediates, and finished products in accordance with applicable procedures and equipment qualification requirements.
• Identify tests or results requiring further attention and implement corrective actions.
• Review and approve analytical data, which may include analytical product release depending on regional regulatory requirements.
• Support laboratory investigations, including out-of-specification results, and ensure effective corrective actions are implemented.
• Understand, communicate, and present QC metrics; attend and lead Tier meetings.
• Ensure appropriate procedures are in place and QC activities comply with internal procedures, cGMP requirements, and relevant safety standards.
• Assist with implementation of continuous improvement actions for laboratory processes.
• Assist analysts with analytical and microbial instrumentation; ensure instrument availability, timely preventive and repair maintenance, and material qualifications.
• Plan instrument needs through ongoing technical and technological intelligence and apply corrections or corrective actions to reduce recurring instrumentation failures.
• Assist with periodic inspections of laboratory facilities to ensure operation in accordance with GMP and Good Laboratory Practices and maintain audit readiness.
• Support supplier, internal, and regulatory audits when required.
• Serve as backup for the Lab Manager when required.
• Generate and manage non-hazardous and hazardous waste in accordance with internal procedures and local and federal regulations.

Benefits

• Paid time off, including vacation, holidays, and sick time
• Medical insurance
• Dental insurance
• Vision insurance
• 401(k)
• Eligibility to participate in short-term incentive programs

What This Job Offers

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