Kedrion Biopharma · 2 days ago

Quality Assurance Specialist

Duncanville, TX

Full-time

Onsite

Entry, Mid Level

3+ years exp

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Health Care

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Responsibilities

Ensure general understanding of all applicable state, federal regulations, industry and corporate policies.

Ensure compliance with cGMP, Kedplasma DCOP’s, and other Company standards to meet regulatory requirements.

Review and investigate final shipment release deviations including accurate labeling and documentation.

Participate in review of Donor Center Operating Procedures (DCOPs) and validating processes.

Investigate, track/trend and follow up on corrective actions and preventative measures for center non-conformances.

Participate in internal and external audits of the facility.

Monitor quality control checks on products stored and shipped by the center.

Encourage and participate in continuous quality improvement process.

Prepare and submit epidemiological data for reporting requirements.

Ensure staff is trained and maintain their competency to perform all assigned tasks.

Ensure proficiency testing, complaint investigations, and staff training are properly performed and documented.

Qualification

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Fiscal operationsBiomedical field experienceEnglish language proficiencyComputer software proficiency DMSComputer software proficiency eQueComputer software proficiency Microsoft OfficeProblem-solvingCommunicationInfluenceSupervisionConflict resolutionCustomer servicePeople skillsBlood-Borne Pathogens KnowledgeAdaptability

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