Kedrion Biopharma · 2 days ago

Quality Assurance Specialist

Austin, TX

Full-time

Onsite

Entry, Mid Level

3+ years exp

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Responsibilities

Ensure understanding of all applicable regulations and company policies.

Oversee compliance with cGMP, DCOPs, and other standards.

Review and investigate final shipment release deviations.

Participate in reviewing and validating processes.

Review quality and compliance issues with management.

Provide reports on facility compliance.

Investigate and follow up on corrective actions for non-conformances.

Participate in internal and external audits.

Ensure proper documentation, equipment maintenance, and QC checks.

Encourage continuous quality improvement process.

Prepare and submit epidemiological data.

Ensure staff training and competency maintenance.

Perform CLIA proficiency testing and complaint investigations.

Qualification

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Fiscal operationsBiomedical field experienceEnglish language proficiencyOccupational exposure to blood-borne pathogensProblem-solvingCommunicationInfluenceSupervisionConflict resolutionCustomer servicePeople skills

Required

Bachelor’s degree in science or minimum of 2 years plasma center experience required

Previous work experience demonstrating decision-making ability, ability to effectively communicate with and positively influence people, familiarity with fiscal operations, supervisory responsibility, conflict resolution, and customer service

Excellent communication skills and ability to conduct oral presentations

Excellent people skills which extend to a diverse group of individuals and demographics

Three to five years of working experience in a biomedical field preferred

Ability to speak, read, and write in English

Professional appearance and demeanor

Ability to operate computer software including DMS (with training), eQue, and Microsoft Office

Occupational exposure to blood-borne pathogens