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JOB DESCRIPTION

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The Quality Assurance Specialist (QAS) will be a member of the Stability Biologics Quality Dept. to perform quality record reviews, batch release, record retention, data entry, auditing, investigations and document control activities.  The QAS will be responsible for quality assurance metrics, CAPA/NCMR and maintaining all quality records/batch records in a secure and controlled manner.  The QA Specialist will also be responsible for ensuring all policies and procedures are in compliance with appropriate FDA, AATB, states, and Stability Biologics standard operating procedure.

 

PRINCIPAL RESPONSIBILITIES

 

• Donor eligibility reviews.

• Batch record review and release.

• Review and approval of all quality records.

• Review and analyze test reports.

• Perform CAPA/NCMR/Deviation investigations and documentation.

• Maintain databases and logs of CAPA/NCMR/Deviation.

• Documenting and investigating Complaints.

• Controlling and releasing documents through the Document Control System.

• Maintain training records.

• Conduct training as necessary.

• Conducting internal audits.

• Conducting supplier audits.

• Maintain supplier qualification documents.

• Maintain Approve Supplier List.

• Maintain all quality records in a controlled and secured location.

• Initiate Non-conformances and participate in investigations.

• Establish and implement Standard Operating Procedures and Forms.

• Assist in audits and inspections.

• Log donors and production lots into database.

• Orders supplies for quality assurance records and data management.

• Prepare trends and graphs.

• Maintaining and provide QA metrics to management.

• Maintain up to date knowledge with respect to relevant state-of-the-art technology, equipment, and/or systems.

• Any other duties or responsibilities necessary.

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REQUIRED SKILLS & KNOWLEDGE

 

• BS degree in a scientific discipline (Chemistry, Biology, Physics, Bio-Medical Engineering/Chemical Engineering, etc.) with at least 1 year QA experience or a High School diploma with at least 4 years experience in quality assurance in a regulated industry.

• Knowledge of AATB Standards and 21 CFR 1271 regulations.