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 required
- 0-1 year of quality experience in an FDA regulated environment for HCT/Ps and/or medical devices preferred
Salary : $55,000
