Quality Control Coordinator

CI – The Manufacturing Career HUB•City of Hudson, NY

6d•Onsite

About The Position

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 oversite investigations, inspections, incoming materials, documentation, and quality system activities.

Requirements

High School Diploma required
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.
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.

Nice To Haves

bachelor’s degree preferred

Responsibilities

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.
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.
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.
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.
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.
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.
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.