Quality Control Specialist

Purpose

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

Responsibilities

• Inspect HCT/P products in accordance with standard operating procedures and regulatory requirements.


• Sort and segregate acceptable and unacceptable HCT/P products.


• Perform in-process and post processing Quality Control inspections and testing.


• Prepare shipping documents and packages in accordance with standard operating procedures.


• Communicate and escalate inspection or quality control issues to Management/Quality Control as necessary.


• Initiate and review quality control records to include environmental monitoring, and HCT/P inspection.


• Assist in routing, editing, and finalizing controlled documents, ensuring consistency and compliance to formatting and template requirements.


• Initiate, review, and investigate quality events.


• 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.


• Start job duties on time, stay on the job throughout the assigned shift to complete duties properly, and attend all scheduled meetings and appointments.


• Work outside normal business hours during weekdays and on the weekend as needed to support business/operational needs.


• Perform other related 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


• Ability to work in a fast-paced environment.


• Effective verbal and written communication skills.

Qualifications/Requirements

• High school diploma or equivalent required.


• Bachelor’s degree in a biological science or related field, from an accredited college or university required.


• At least 1 year of experience in an FDA regulated environment for HCT/Ps and/or medical devices preferred.


• 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.