Lead Quality Inspector (APU 3 2nd Shift)

Nemera•Buffalo Grove, IL

16h

About The Position

The Lead Quality Inspector assists the Operational Quality Manager in coordinating and executing quality objectives with other Lead Quality Inspectors to maximize product quality and operating-system effectiveness while minimizing costs. The role directs and coordinates Quality Inspectors who evaluate goods, and performs all functional duties and responsibilities of a Quality Inspector. The position plans inspector schedules, assignments, and production sequences; reviews charts, work orders, records, and reports to determine resource needs; checks data and documentation for accuracy and timely processing; and analyzes statistical data, inspection methods, and sample plans to assess and establish quality standards. It supports oversight and disposition of nonconforming production material, manages batch release and CoC/CoA creation, and ensures in-process and start-up requirements, LRP closure, and company cGMP compliance. The Lead Quality Inspector prepares quality and safety reports, consults with management and staff about work-related issues, observes inspectors’ work for conformity with quality-system standards, and participates in customer complaint investigations. The role uses problem-solving methods to reduce failures, provides training, coaches and mentors employees, and supplies performance feedback to Quality Managers. It also carries out responsibilities defined by the company quality system and supports company policies, applicable FDA and ISO requirements, health and safety requirements, and continuous-improvement initiatives. This is a second-shift position, Monday through Friday, 2:00 PM to 10:30 PM. Work takes place in a clean-room manufacturing environment that may have moderate noise and requires appropriate cleanroom apparel. The role requires travel between office and production departments and company buildings.

Requirements

Associate degree or at least 3 years of related work experience, including at least 1 year in a leadership role.
Ability to perform all Quality Inspector functional job responsibilities.
Good working knowledge of raw materials, production processes, costs, and other techniques used to maximize effectiveness.
Knowledge of inspection tools and their use and maintenance.
Self-directed, with demonstrated planning and organizing skills.
Able to lift up to 35 pounds.
Able to sit, stand, and walk for 80% of the shift.

Nice To Haves

Excellent oral and written communication skills.
Ability to apply basic mathematical concepts.
General knowledge of PC applications such as Microsoft Word, Excel, and database software.

Responsibilities

Assist the Operational Quality Manager and other Lead Quality Inspectors in coordinating and executing quality objectives.
Direct and coordinate Quality Inspectors who evaluate goods, and perform Quality Inspector functional duties.
Plan and establish QC inspector schedules, assignments, and production sequences to meet production goals.
Review charts, work orders, records, reports, data, and documentation for resource requirements, accuracy, correctness, and timely processing.
Analyze statistical data, inspection methods, and sample plans to assess current standards and establish quality plans.
Assist in overseeing nonconforming product during production and manage daily material disposition.
Manage batch release and create CoC/CoA documentation.
Ensure in-process and start-up requirements are met for LRP and usage decisions; consult the Operational Quality Manager about discrepancies.
Ensure LRP closure and compliance with company cGMP.
Prepare quality and safety reports.
Consult with management and staff on work-related issues or complaints, with support from the Operational Quality Manager and Quality Engineer.
Observe Quality Inspectors’ work to ensure compliance with quality-system standards.
Participate in customer complaint investigations.
Use problem-solving techniques to reduce internal and external failures.
Provide training to the QC department as needed.
Execute responsibilities defined within the company quality system and support company policies, applicable FDA and ISO requirements, health and safety requirements, and continuous-improvement initiatives.
Coach and mentor employees and provide performance feedback to Quality Managers to support performance reviews.
Perform other duties as assigned.