Supervisor, Clinical Quality D

PCI Pharma Services•Rockford, IL

16d

About The Position

The Clinical Quality Supervisor oversees the daily operations of the Clinical Quality Department, including In-Process/Finished Goods Inspection and, when required, Receiving Inspection. The role resolves quality issues and deviations, develops and mentors staff, and maintains quality standards in compliance with current Good Manufacturing Practices, company Standard Operating Procedures, and customer requirements. The Supervisor leads inspection teams across In-Process/FG Inspection, Distribution and Returns Inspection, and Clinical Quality Label Room Inspection. The position allocates resources, plans workloads, oversees quality operations, supports employee development, and drives quality improvement. It also works with Clinical and Operations teams to address quality concerns, make risk-based decisions, improve documentation, and ensure continuity between shifts. The role may require overtime and/or weekend work. The hiring rate is $62,960–$70,830, with eligibility for an annual performance bonus. PCI offers full-time employees paid time off, health insurance coverage including dental and vision, a flexible spending account, and a 401(k).

Requirements

Associate's degree in a related field and/or 1–3 years of related experience and/or training.
Basic mathematical skills.
Intermediate computer skills, including the ability to perform more complex computer tasks and knowledge of various computer programs.
Full professional proficiency in speaking, reading, and writing fluently and accurately at all levels pertinent to professional needs.
Very high reasoning ability, including defining problems, collecting data, establishing facts, drawing valid conclusions, interpreting technical instructions in mathematical or diagram form, and handling abstract and concrete variables.
High standard of report writing.

Nice To Haves

Ability to identify and resolve problems in a timely manner.
Willingness to make decisions.
Ability to conduct oneself professionally.
Excellent time management skills.

Responsibilities

Supervise resource allocation and workload planning for In-Process/FG Inspection, Distribution and Returns Inspection, and Clinical Quality Label Room Inspection.
Direct Quality Operations activities and supervise quality inspectors, coaching them toward high performance goals and PCI standards.
Oversee quality improvement processes across Clinical Quality Inspection functions, including training, mentoring, and equitable development of direct reports.
Resolve quality issues across Clinical departments using applicable SOPs and written guidance, making risk-based decisions that balance product quality and operational requirements.
Organize and lead department and team meetings, including Clinical Batch Record improvement meetings.
Generate and present Quality Operations metrics and key performance indicators to PCI management and internal teams as needed.
Review and interpret customer standards, procedures, specifications, records, forms, Batch Records, SOPs, work instructions, and job aids.
Review and approve internal and customer-based Batch Record specifications required for production packaging.
Provide daily feedback and collaborate with Operations on quality and business matters.
Ensure internal and external Right First Time documentation compliance across functional areas and host weekly meetings with Quality and Operations leadership to discuss errors and preventive measures.
Study and standardize departmental work practices to improve quality and team compliance.
Promote continuity between quality shifts by communicating relevant quality events, staffing issues, and management messages.
Initiate Quality Operations events and document them in the QMS; determine root causes and corrective actions, and assist with investigation responses to the Senior Supervisor or Manager.
Gather information and enter Non-Conforming Material Reports (NONCs) in the QMS.
Communicate employee disciplinary issues to HR and Quality Management, seek recommendations, and document and administer counseling as appropriate.
Maintain and monitor departmental quality testing equipment as needed.