About this role
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.