Quality Assurance Specialist

Purpose:

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

Duties & Responsibilities:

• Inspect HCT/P products in accordance with standard operating procedures and regulatory requirements.
• Sort and segregate acceptable and unacceptable HCT/P products.
• 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 proficient working knowledge of AATB Standards, cGMP/cGTP, and the organizations Policies and Procedures.
• Starting your job duties on time, staying on the job throughout the assigned shift to complete duties properly, and attending all scheduled meetings and appointments

• Perform other related duties as assigned.

Skills & Abilities:

• Excellent attention to detail and organization skills
• Self-motivated
• Ability to work in a fast-paced environment.
• Effective verbal and written communication skills.
• Ability to secure and maintain a favorable background investigation and clearance

Education & Experience:

• Entry Level position
• Bachelor’s degree in a biological science or related field
• 0-1 year of quality experience in an FDA regulated environment for HCT/Ps and/or medical devices