Senior Quality Assurance Specialist
Position Title: | Senior Quality Assurance Specialist |
Department: | Quality Assurance |
Reports To: | Head of Quality Assurance |
Job Type: | Full Time |
Shift: | Monday - Friday 08:00 AM - 05:00 PM |
Exempt / Non-Exempt: | Exempt |
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).