Licensure & Notification Specialist
On-siteShreveport, Louisiana, United States
Job Summary
Maintain current product licensure with the FDA, submit new applications and supplements, and coordinate with national and state agencies to ensure permits and accreditations remain current. Identify donors and products requiring notification of deferrals or recalls, report positive test results to state agencies, and prepare annual reports outlining operational changes. Coordinate with operations on product validations, review data for licensure submissions, and develop corrective actions for deviations found during internal or external inspections. Accompany external inspectors, document discrepancies, and ensure timely implementation of training and compliance updates.
Required Qualifications
- Bachelor's degree from an accredited college or university in a related field
- Two (2) years of experience in blood banking, quality assurance or a bioscience industry
- Associate's degree plus four (4) years of experience in blood banking, quality or bioscience field
- Equivalent combination of education and experience sufficient to perform the essential job duties
- Prior work experience in a blood center or hospital laboratory environment
- Self-motivated
- Dependable
- Punctual
- Effective organizational and communication skills
- Familiarity with FDA regulations governing blood banking
- Familiarity with AABB standards
- Familiarity with OSHA regulations
- Familiarity with Good Manufacturing Practice (cGMP)
- Positive approach toward donors and other team members
- Highly professional manner at all times
- Ability to maintain confidentiality of various information
- Ability to proactively identify collaborative solutions to facilitate resolution of conflicts
- Ability to evaluate diverse processes (e.g. financial, compliance, lean, corrective actions) for potential improvement
- Valid driver's license
- Insurable by commercial auto insurance carrier
Desired Qualifications
- Prior work experience in a blood center or hospital laboratory environment highly desirable
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