Quality Control Specialist (Distribution Operations)

Purpose

The Quality Control Specialist is responsible for ensuring that all products and quality control processes meet established quality requirements.

Responsibilities

• Inspect HCT/P and Medical Device products in accordance with standard operating procedures and regulatory requirements
• Practice proper material handling, identification, segregation, and storage methods
• Inspect incoming materials and finished devices to defined inspection procedures and requirements
• Perform rework in accordance with standard operating procedures
• Initiate, review, and investigate quality events
• Communicate and escalate inspection or quality control issues to Quality Management or Operations Management as applicable
• Interface with Distribution, and other personnel to ensure good communication and coordination of activities
• Initiate and review quality control records to include environmental monitoring, scrap processing, and returns review
• Assist in routing, editing, and finalizing controlled documents, ensuring consistency and compliance to formatting and template requirements
• Support internal and external audits
• File and maintain records in accordance with standard operating procedures
• Maintain a working knowledge of FDA 21 CFR 1271, FDA 21 CFR 820, AATB standards, ISO Standards, cGMP/CGTP, other relevant regulations/standards, and internal organizational policies and standard operating procedures
• Maintain acceptable attendance and punctuality for scheduled work hours and meetings
• Ensure completion of assigned tasks and responsibilities within defined timeframes
• Flexibility to work outside of normal business hours during weekdays or weekends with reasonable advance notice to support business/operational needs when necessary
• Perform other duties as assigned

Skills

• Ability to work independently and in a team environment
• Excellent attention to detail and organization
• Excellent written and verbal communication
• Highest level of ethics and integrity
• Ability to lead and motivate the right behaviors
• Ability to multi-task and work in a fast-paced environment
• Strong technical writing
• Effective project management
• Proficiency in Microsoft Office
• Excellent attention to detail and organization skills
• Self-motivated
• Effective verbal and written communication skills
• Adherence to all safety, regulatory, and quality requirements

Qualifications/Requirements

• High school diploma or equivalent required
• Bachelor’s degree in a biological science or related field, from an accredited college or university preferred
• At least 1 year of experience in an FDA regulated environment for HCT/Ps and/or medical devices
• Bachelor’s degree may be substituted to meet up to 4 years of experience requirements
• Master’s degree may be substituted to meet up to 6 years of experience requirements
• Clearance of favorable background investigation required