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Quality Control Specialist

3 months ago

San Antonio, United States Extremity Care Full time
Job DescriptionJob DescriptionSalary: $24.00 per hr

Department: Quality Control Shift: Monday-Friday 8:30am-5:00pm

 

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