Consumables Manufacturing Supervisor (3rd Shift)

DiaSorin•Northbrook, IL

40d•$65,000 - $87,000

About The Position

The Supervisor of Microarray Manufacturing oversees third-shift manufacturing operations, including personnel, equipment, production planning, logistics, and upstream slide preparation processes. The role ensures efficient, compliant operations under cGMP and QSR requirements, maintains manufacturing procedures, manages product configurations, and implements process changes. Responsibilities include supervising production associates, overseeing equipment maintenance and calibration, troubleshooting complex equipment, and executing validation and performance qualification protocols for new or modified processes. The Supervisor also supports investigations and resolution of audit findings, non-conformances, corrective and preventive actions (CAPAs), and customer complaints while advancing operational efficiency, product quality, and continuous improvement.

Requirements

Associate's degree in Engineering Technology, Industrial Technology, Chemistry, Business, or equivalent.
At least 5 years of related experience and/or training, or an equivalent combination of education and experience.
At least 3 years of supervisory experience.
High proficiency in cGMP regulations, including 21 CFR 820, CMDR, and ISO 13485, and their impact on manufacturing.
High proficiency with computer skills sufficient to maintain effective electronic ERP systems and manufacturing software.
High proficiency in reading and comprehending complex instructions, procedures, and repair manuals.
High proficiency in basic mathematics, including operations with whole numbers, common fractions, and decimals.
Adaptability and openness to change, with the ability to work in ambiguous situations and respond to new information and unexpected circumstances.
Strong organization, time management, and prioritization skills.
Ability to meet tight deadlines and manage multiple tasks simultaneously.
Strong verbal and written communication, presentation, and facilitation skills.
Excellent project management skills.

Responsibilities

Train and develop the microarray team to meet corporate quality and throughput objectives.
Ensure microarray manufacturing work is conducted according to approved SOPs.
Review and approve DMRs and BPRs, and author them when applicable.
Approve DHRs in a timely fashion for each product lot.
Assist with equipment validations to ensure processes and equipment are validated.
Prioritize, schedule, and implement preventative maintenance and calibration plans for microarray manufacturing equipment.
Ensure microarray manufacturing best practices are followed when using manufacturing equipment.
Execute equipment qualification protocols and procedures to meet applicable domestic and international regulatory requirements.
Assist in writing and implementing changes to controlled documents, such as SOPs and specifications.
Work cross-functionally with Engineering, R&D, Production Control, QA, Manufacturing Engineering, and Quality Control.
Oversee manufacturing personnel, equipment, production planning, logistics, and upstream slide preparation processes.
Troubleshoot complex manufacturing equipment.
Support investigations and resolution of audit findings, non-conformances, CAPAs, and customer complaints.
Perform other duties and special projects as assigned.