What are the responsibilities and job description for the Quality Control Specialist position at Extremity Care?
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 preferred.
•0-1 year of quality experience in an FDA regulated environment for HCT/Ps and/or medical devices
