41 applicants
KEDPLASMA · 3 days ago
Quality Assurance Specialist
Pasadena, TX
Full-time
Onsite
Mid Level
3+ years exp
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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.
Participate in review of Donor Center Operating Procedures and validating processes.
Review quality and compliance issues periodically.
Provide accurate reports of facility’s compliance.
Investigate, track, and follow up on corrective actions for non-conformances.
Participate in internal and external audits.
Ensure correct documentation, equipment maintenance, and supplies management.
Encourage and participate in continuous quality improvement process.
Monitor, prepare, and submit epidemiological data.
Ensure staff training and competency maintenance.
Perform CLIA proficiency testing and complaint investigations.
Qualification
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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
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
Ability to sit or stand for extended periods of time
Ability to tug, lift, and pull up to fifty (50) pounds
Be able to bend, stoop or kneel and climb stairs and/or ladder
Occupational exposure to blood-borne pathogens
Able to travel by plane and drive car
While performing the duties of this job, the employee is regularly required to stand; use hands to handle or feel objects, tools or controls
Preferred
Three to five years of working experience in a biomedical field preferred
Benefits
Medical, vision and dental insurance
Life and AD&D insurance
Paid holidays
PTO accrual
Company
KEDPLASMA
KEDPlasma is a pharmaceutical company.
501-1,000 employees
Funding
Current Stage
Late StageRecent News
2023-11-01
Company data provided by crunchbase
