About the role
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.