Quality Control Specialist

Purpose

The Quality Control Specialist is responsible for ensuring that all products and quality control processes meet established quality requirements.

Responsibilities

- 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 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 working knowledge of FDA 21 CFR 1271, FDA 21 CFR 820, AATB standards, ISO Standards, cGMP/CGTP, other relevant regulations/standards, and internal organizational policies and standard operating procedures.

- Start job duties on time, stay on the job throughout the assigned shift to complete duties properly, and attend all scheduled meetings and appointments.

- Work outside normal business hours during weekdays and on the weekend as needed to support business/operational needs.

- Perform other related duties as assigned.

Skills

- Ability to work independently and in a team environment.

- Excellent attention to detail and organization.

- Excellent written and verbal communication.

- Highest level of ethics and integrity.

- Ability to lead and motivate the right behaviors.

- Ability to multi-task and work in a fast-paced environment.

- Strong technical writing.

- Effective project management.

- Proficiency in Microsoft Office.

- Excellent attention to detail and organization skills

- Self-motivated

- Ability to work in a fast-paced environment.

- Effective verbal and written communication skills.

Qualifications/Requirements

- High school diploma or equivalent required.

- Bachelor’s degree in a biological science or related field, from an accredited college or university 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.