Quality Control Analyst - FDA-Regulated HCT/P

Extremity Care, LLC; San Antonio (TX); Sur place; USD 48 000 - 66 000; Plein temps

Résumé du poste

Extremity Care, LLC is seeking a Quality Control Specialist to Ensure products and processes meet established requirements. You will inspect HCT/P products, sort and segregate items, and perform in-process and post-processing QC inspections and testing.

The role involves preparing shipping docs, communicating QC issues to management, and maintaining QC records. Candidates should have a biological science degree and FDA-regulated environment experience, with strong attention to detail and

Qualifications

• High school diploma or equivalent required.
• Bachelor’s degree in a biological science or related field required.
• At least 1 year of experience in an FDA regulated environment for HCT/Ps and/or medical devices preferred.
• Bachelor’s degree may be substituted to meet up to 4 years of experience requirements.
• Master’s degree may be substituted to meet up to 6 years of experience requirements.
• Clearance of favorable background investigation required.

Responsabilités

• Inspect HCT/P products in accordance with standard operating procedures and regulatory requirements.
• Sort and segregate acceptable and unacceptable HCT/P products.
• Perform in-process and post processing Quality Control inspections and testing.
• Prepare shipping documents and packages in accordance with standard operating procedures.
• Communicate and elevate 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 knowledge of FDA 21 CFR 1271, FDA 21 CFR 820, AATB standards, ISO Standards, cGMP/CGTP, and internal policies.

Connaissances

Independent work

Attention to detail

Written & verbal communication

Ethics & integrity

Leadership

Multi-tasking

Technical writing

Project management

MS Office

Teamwork

Formation

Bachelor’s degree in biological science or related field

Master’s degree substitution for experience

Description du poste

Extremity Care, LLC is seeking a Quality Control Specialist to Ensure products and processes meet established requirements. You will inspect HCT/P products, sort and segregate items, and perform in-process and post-processing QC inspections and testing.

The role involves preparing shipping docs, communicating QC issues to management, and maintaining QC records. Candidates should have a biological science degree and FDA-regulated environment experience, with strong attention to detail and