Quality Control Specialist

Purpose:

The Quality Control Specialist is responsible for supporting production by ensuring that all products, donor records and quality control processes meet established quality requirements.

This support is achieved through batch record review, verification of adherence to equipment maintenance/calibration schedules, support of equipment qualifications, environmental monitoring, and assisting with deviation/nonconformance investigations.

Duties & Responsibilities:

• Technical review of HCT/P production records in accordance with standard operating procedures and regulatory requirements.
• Communicate and escalate inspection or quality control issues to Management/Quality Control as necessary.
• Review quality control records to include equipment cleaning/maintenance, environmental monitoring, and supply inspections.
• Assist in routing, editing, and finalizing controlled documents, ensuring consistency and compliance to formatting and template requirements.
• Initiate, review, and investigate quality events.
• Support and/or perform 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, and industry standards.
• Start job duties on time, stay on the job throughout the assigned shift to complete duties properly, and attend all scheduled meetings and appointments.
• Perform other related duties as assigned.

Skills & Abilities:

• Organized and excellent attention to detail
• Self-motivated
• Effective verbal and written communication
• Ability to work in a team environment or independently, as needed
• Experience working with Microsoft programs.
• Ability to work standing or sitting for 8-10 hours
• Ability to lift 25lbs
• Adherence to all safety, regulatory, and quality requirements
• Continuous improvement
• Ability to document work with legible handwriting.
• Ability to work in a fast-paced environment.

Education & Experience:

• High school degree or equivalent required.
• Bachelor’s degree in biological science or related field preferred.
• 1-3 years of experience in an FDA regulated environment for HCT/Ps and/or medical devices preferred.