Summary:
The QC Coordinator supports daily Quality Control activities to ensure compliance with GMP, company procedures, and regulatory requirements for OTC Drug, Medical Device, Cosmetic, and Consumer Products. This role works closely with Quality, Production, and Operations to support inspections, investigations, documentation, and quality systems.
Essential Duties and Responsibilities:
Quality & Compliance
- Support daily QC operations and quality system activities.
- Provide quality guidance to Production and Operations teams.
- Participate in quality meetings and continuous improvement initiatives.
- Assist with internal, customer, and regulatory audits.
Documentation & Batch Records
- Review batch records and production documentation for accuracy and GMP compliance.
- Maintain quality records and document control systems.
- Support annual batch record reviews.
Investigations & CAPA
- Assist with investigations, nonconformances, SCARs, and corrective actions (CAPA).
- Participate in root cause analysis and process improvement activities.
- Support Change Control, Process Validation, and Process Qualification activities.
Incoming Materials & Supplier Quality
- Support incoming inspections and bulk material evaluations.
- Coordinate testing samples and supplier qualification activities.
- Assist with supplier quality monitoring.
Training & Facility Programs
- Support training records and deliver GMP training.
- Assist with environmental monitoring, calibration programs, and SOP reviews.
- Support product disposition and quality initiatives.
Production Support
- Serve as backup for QC Inspectors and perform in-process inspections as needed.
- Support line inspections, sample submissions, retain sample management, and quality reporting.
Physical Requirements
- Stand, walk, sit, bend, and reach for extended periods.
- Lift up to 25 pounds occasionally.
- Wear required PPE in manufacturing and laboratory environments.
- Inspect materials, labels, and production areas.
Qualifications
Education
- High School Diploma required; Bachelor's degree preferred.
Experience
- Minimum 3 years of Quality Control, Quality Assurance, or Manufacturing Quality experience in a GMP environment.
- Experience with OTC Drug, Medical Device, Cosmetic, Food, or Consumer Products preferred.
Knowledge & Skills
- Knowledge of GMP regulations and quality systems.
- Strong attention to detail and documentation skills.
- Excellent organization, communication, and problem-solving abilities.
- Proficient in Microsoft Office and electronic quality systems.
- Ability to work independently and collaborate across departments.
Pay: $70,000.00 per year
Benefits:
- 401(k)
- 401(k) matching
- Employee assistance program
- Health insurance
- Paid time off
- Professional development assistance
- Referral program
Experience:
- Quality control: 3 years (Preferred)
- Attention to detail: 1 year (Preferred)
- CGMP: 1 year (Preferred)
Ability to Commute:
- Hudson, NY 12534 (Required)
Work Location: In person
