Quality Assurance Specialist

Extremity Care; Conshohocken (Montgomery County); On-site; USD 60,000 - 76,000; Full time

Job summary

Extremity Care seeks a Quality Assurance Specialist to ensure all products and QC processes meet established quality requirements in a regulated environment. You will review records, inspect HCT/P items, and maintain regulatory compliance under FDA and ISO standards.

Responsibilities include supporting audits, identifying quality events, and communicating issues to management. Strong attention to detail, ethics, and the ability to work independently are essential.

Qualifications

• Requires an Associate degree in a biological science, engineering, or related field.
• Bachelor's degree in a biological science, engineering, or related field preferred.
• 0–2 years of FDA-regulated environment experience preferred for HCT/Ps, medical devices, pharmaceuticals, or related fields.

Responsibilities

• Review quality control records, including equipment cleaning/maintenance, environmental monitoring, and supply inspections.
• Inspect HCT/P products per SOPs and regulatory requirements.
• Sort and segregate acceptable and unacceptable HCT/P products.
• Identify and initiate quality events.
• Communicate and escalate inspection or QC issues to Management when necessary.
• Support internal and external audits.

Skills

Independent work

Attention to detail

Written and verbal communication

Ethics and integrity

Leadership

Multi-tasking

Technical writing

Project management

Microsoft Office

Education

Associate degree

Bachelor's degree preferred

Tools

Microsoft Office

Job description

Purpose

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

Responsibilities

• Review quality control records to include equipment cleaning/maintenance, environmental monitoring, and supply inspections.
  
• Inspect HCT/P products in accordance with standard operating procedures and regulatory
• Sort and segregate acceptable and unacceptable HCT/P
• Identify and initiate quality events.
• Communicate and escalte inspection or quality control issues to Management when necessary.
• Support internal/external audits.
• 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.

Qualifications/Requirements

• Associate degree (or 60 hours from an accredited college or university) in a biological science, engineering, or related field required.
• Bachelor's degree in a biological science, engineering, or related field preferred.
• At least 0-2 years of experience in an FDA regulated environment for HCT/Ps, medical devices, pharmaceuticals, and/or related field preferred.
• Additional relevant work experience may be substituted for the degree requirement on a year-for-year basis.
• Clearance of favorable background investigation required.