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Company

Original Job Post

Kedrion Biopharma · 2 days ago

Quality Assurance Specialist

Pasadena, 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 standards.

Review final shipment release deviations and investigate.

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

Review quality issues with management and compliance issues with staff.

Provide compliance reports to management.

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

Participate in internal and external audits.

Ensure correct documentation, equipment maintenance, and supplies management.

Perform QC checks on products stored and shipped.

Encourage continuous quality improvement process.

Monitor, prepare, and submit epidemiological data.

Ensure staff training, competency maintenance, and CLIA proficiency testing.

Evaluate staff performance and document competency evaluations.

Qualification

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Fiscal operationsBiomedical field experienceEnglish language proficiencyComputer software proficiency DMSComputer software proficiency eQueComputer software proficiency Microsoft OfficeProblem-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