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 preferred.

Knowledge, Skills, and Abilities• Working knowledge of GMP regulations and quality system requirements. • Strong attention to detail and documentation review skills. • Ability to investigate issues and identify potential root causes. • Strong organizational and time management skills. • Ability to prioritize multiple assignments in a fast-paced environment. • Effective verbal and written communication skills. • Proficiency in Microsoft Office applications and electronic quality systems. • Ability to work independently while collaborating effectively across departments.

Company Website

Premier Brands of America Inc.

Company Profile

Premier Brands of America is a privately held manufacturer and marketer of health and wellness products with a manufacturing facility located in Hudson, New York. With more than 50 years of industry experience, the company develops and manufactures both private label and nationally recognized consumer brands across the foot care, first aid, skin care, and shave categories. Premier provides end-to-end product development, manufacturing, packaging, and fulfillment services to leading retailers throughout the United States. Committed to innovation, quality, and continuous improvement, Premier Brands offers employees the opportunity to build rewarding careers in a dynamic manufacturing environment.