Maintains current product licensure with the Food and Drug Administration (FDA) and submits new licensure applications and supplements. Responsible for donor deferral and consignee notifications as required in the Code of Federal Regulations (CFR); e.g., 21 CFR 630.40, 21 CFR 610.46, and 21 CFR 610.47. Coordinates with national organizations to maintain accreditations and with state agencies to ensure permits required to maintain operations are current. In support of product licensures, the LNS monitors and compiles data related to product validations in preparations for FDA submissions and the availability of the product for distribution. When required by state or federal guidelines, the LNS reports donor and product testing results to state and federal agencies.
DUTIES AND RESPONSIBILITIES:
- Maintains an understanding of requirements provided in the CFR, FDA Guidance Documents, AABB Standards, and LifeShare policies and procedures as they relate to the collection, testing, processing, storage, and distribution of blood and blood components.
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Identifies donors and products requiring notification of deferrals and recalls and ensures notifications are completed and documented in the timeframes required by FDA regulations.
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Reports positive donor test results to state agencies with time frames specified by state code.
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Coordinates with operations on product validations to monitor and review data for potential licensure submissions. Provides feedback on products not meeting validation requirements and assists with investigations and development of training and corrective actions to prevent future occurrences.
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Prepares submissions to the FDA for initial product licensure and updates. Provides process updates to the FDA to ensure approved product licensures are current and meet all revisions published in regulations and guidances.
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Prepares an annual report to the FDA outlining current operations and changes implemented during the previous year.
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Reviews changes in AABB Standards and coordinate with quality services and operations teams to ensure policies and procedures are updated to incorporate all changes.
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Assists with, or conducts, training for current Good Manufacturing Practices (cGMP), quality procedures, regulatory issues, and deviation reporting.
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Prepares or reviews BPDRs and internal deviation reports within required time frames. Performs effectiveness checks to ensure deviation corrective actions were implemented and any required training was completed to avoid further occurrences.
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Assists with developing validation protocols to ensure regulatory requirements are addressed and reviews summary data to determine if acceptance criteria were met.
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Monitors training completion on new procedures and equipment to ensure timely implementation.
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Serves as a resource to teams on quality and regulatory issues.
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Accompanies external inspectors of operational areas while on premises. Provides information and requested documents. Coordinates meetings between inspector and team leadership upon request. Documents scope of the inspection, records reviewed, teams interviewed, and identified discrepancies. Provides a report of all inspections to the Supervisor, Quality and Regulatory Services and center management following the inspection.
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Takes immediate corrective action where there is a breach in current good manufacturing practice (cGMP), SOPs, or safety procedures that could jeopardize the safety of donors/patients, the safety of teams, or the quality of blood components. Immediately notifies team leadership for documentation and additional investigation regarding the process deviation.
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Ensures corrective action is developed and implemented for any discrepancies found during internal or external inspections/audits.
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Attends meetings and seminars to maintain proficiency and knowledge of operational areas and quality/regulatory services as they pertain to the blood center.
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Models LifeShare’s mission and values, integrating them into daily decisions, behaviors and actions.
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Promotes cooperation and communication within a team to achieve Company and departmental goals and deliverables.
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Meet and exceed customer expectations and adhere to established quality practices while seeking to continually improve work performance.
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Completes other assignments and duties as may be assigned.
KNOWLEDGE / SKILLS / ABILITIES:
- Bachelor’s degree from an accredited college or university in a related field, plus two (2) years of experience in blood banking, quality assurance or a bioscience industry, or
- Associate’s degree plus four (4) years of experience in blood banking, quality or bioscience field, or an equivalent combination of education and experience sufficient to perform the essential job duties.
- Prior work experience in a blood center or hospital laboratory environment highly desirable.
- Must be self-motivated, dependable, punctual, and have demonstrated effective organizational and communication skills.
- Must be familiar with FDA regulations governing blood banking, AABB standards, OSHA regulations, and Good Manufacturing Practice (cCGMP).
- Must demonstrate a positive approach toward donors and other team members, acting in a highly professional manner at all times.
- Must maintain confidentiality of various information at all times.
- Must be able to proactively identify collaborative solutions to facilitate resolution of conflicts.
- Must be able to evaluate diverse processes (e.g. financial, compliance, lean, corrective actions) for potential improvement.
PHYSICAL DEMANDS / WORKING CONDITIONS / ENVIRONMENT:
- Work is generally performed in a office setting, with active prescence throughout the organization.
- Routine work schedule, with occasional after hours on-call rotation.
- Low risk of exposure to infectious diseases from blood and blood products. Work is generally performed in corporate office environment.
- Requires occasional travel within the community or to other centers and facilities; must possess a valid driver’s license and be insurable by our commercial auto insurance carrier.
The requirements and physical demands listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations will be made in accordance with the ADA to enable individuals with disabilities to perform the essential job functions.
Disclaimer: The above information on this description has been designed to indicate the general nature and level of work performance by employees within this classification. It is not designed to contain or be interpreted as comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to this job.
