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.