Senior Quality Assurance Specialist

Purpose:

The Senior Quality Assurance Specialist is responsible for verifying operational compliance with the quality system and ensuring that all products and quality control processes meet established quality requirements.

Duties & Responsibilities:

• Review HCT/P donor records in accordance with standard operating procedures and regulatory
• 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
• Assist with review and processing of document change requests and change control
• Assist in routing, editing, and finalizing controlled documents, ensuring consistency and compliance to formatting and template requirements.
• Assist with development of equipment and process
• Review of validation execution
• Initiate, review, and investigate quality
• Support and/or perform internal and external
• Support new projects and product
• File and maintain records in accordance with standard operating
• Maintain a proficient working knowledge of FDA 21 CFR 1271, 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

 Skills & Abilities:

• Excellent attention to detail and organizational 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:

• Bachelor’s degree in biological science or related field
• At least 3 years in an FDA regulated environment for HCT/Ps and/or medical devices (or related field).