Quality Control Coordinator

Overview

 

Title: Quality Control Coordinator

Compensation: $65,000,yrEmployment Type: Full-Time

 

The Quality Control (QC) Coordinator is responsible for coordinating and supporting day-to-day Quality Control activities to ensure compliance with GMP, company procedures, and regulatory requirements for OTC Drug, Medical Device, Cosmetic, and Consumer Products. This role serves as a key liaison between Quality, Operations, and Production, providing oversiteinvestigations, inspections, incoming materials, documentation, and quality system activities.

 

 

Responsibilities

Quality Control Operations• Coordinate and support daily QC activities within the facility. • Provide guidance and support to Operations and Production teams on quality-related matters. • Participate in Quality meetings and communicate quality concerns, trends, and improvement opportunities. • Assist with implementation and maintenance of quality systems and continuous improvement initiatives.

Batch Record Review & Documentation• Review finished goods batch records for OTC Drug, Medical Device, Cosmetic, and Consumer Products for completeness, accuracy, and GMP compliance. • Support annual batch record review activities. • Review production documentation and identify documentation deficiencies requiring correction or follow-up. • Maintain quality records in accordance with document control requirements.

Investigations, CAPA, and Quality Systems• Conduct initial review and follow-up activities for nonconformance investigations and Supplier Corrective Action Requests (SCARs). • Monitor effectiveness checks associated with corrective and preventive actions. • Support QC CAPA management activities. • Assist in the review and execution of Process Qualifications (PQ), Change Control (CCR), and Process Validation (PV) activities. • Participate in root cause investigations and implementation of corrective actions. Incoming Materials and Supplier Quality• Provide backup support for incoming inspection activities. • Perform bulk material inspections and coordinate sample submissions for testing. • Support vendor qualification activities including Certificate of Analysis (CoA) qualification and identity testing programs. • Assist in supplier quality monitoring and follow-up activities.

Training and Compliance• Support training record administration for hourly direct reports and assigned personnel. • Deliver GMP training and support ongoing compliance education initiatives. • Assist with internal audits and weekly quality inspections. • Support site readiness for customer, regulatory, and certification audits.

Facility Quality Programs• Coordinate temperature monitoring and environmental quality activities as assigned. • Support annual Standard Operating Procedure (SOP) reviews and site quality initiatives. • Participate in calibration program oversight and coordination. • Support product donation review processes and quality disposition activities.

Inspection and Production Support (Backup Responsibilities)• Serve as backup for QC In-Process Inspectors. • Perform in-process inspections during production as required. • Provide production floor coverage including documentation review, line inspections, and quality verification activities. • Support filling line inspections and sample submissions.

• Assist with retain sample management, retain room organization, and annual retain inspections. • Support daily incoming inspection reporting. • Maintain QC cleaning logs and quality records. • Provide backup support for product trend analysis and returned product investigations. • Assist with customer-specific quality documentation requirements, including CoA review activities.

Physical Demands:• Frequently required to sit, stand, walk, bend, reach, and use hands for extended periods. • Ability to inspect production areas and materials throughout the facility. • Ability to lift and move materials up to 25 pounds occasionally. • Ability to wear required PPE and work in manufacturing, warehouse, and laboratory environments. • Visual acuity sufficient to review documentation, labels, packaging components, and inspection samples.

 

Travel: Up to 10% travel may be required.

Qualifications

Education• High School Diploma required (bachelor’s degree preferred)

Experience• Minimum 3 years of experience in Quality Control, Quality Assurance, Manufacturing Quality in a regulated GMP environment. • Experience supporting OTC Drug, Cosmetic, Medical Device, Food, or Consumer Product manufacturing preferred. • Experience with batch record review, investigations, inspections, and quality systems