Overview
Quality Control Specialist (Distribution Operations) Jobs in Conshohocken, PA at Extremity Care
Full Job Description
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
Title: Quality Control Specialist (Distribution Operations)
Company: Extremity Care
Location: Conshohocken, PA
Category:
