Duties and Responsibilities:
Maintains Regulatory Compliance
• Ensures the compliance of all Center activities with Kedplasma DCOP's (Donor Center Operating Procedures) and other Company standards and protocols to meet the regulatory requirements of the FDA, EMEA, Customer Specifications, and other regulatory bodies as required.
• Includes training in all operational areas
• Ensures proper equipment maintenance, calibration and cleaning schedules as required.
• Maintains freezer and refrigerators within required temperature ranges and maintenance requirements.
Manages freezer temperature alerts as necessary.
• Ensures the facility is well-maintained, safe, clean, and neat at all times.
• Maintains a thorough understanding of State and Federal regulations (e.g., FDA approved Standard Operating Procedures, OSHA, CLIA, IQPP Standards and cGMPs) to maintain the highest production standards and ensure facility compliance.
• Reviews test results to ensure that abnormal and reactive test results include prompt unit culling and quarantine, computer entry, execution of lookbacks and final disposition of product.
• Quality Assurance review as needed regarding E&A (Error and Accident) and CAPA follow up and resolution.
• Holds regular meetings with QAM for revisions and updates to training
• Develops an understanding of NAT testing protocols and maintains IQPP Viral Marker Standards.
Problem Resolution
• Maintains all aspects of daily center functions (e.g., personnel, products, donors, computers, etc.).
• Keeps immediate supervisor informed of any irregularities within the center and provides constructive information about process improvements.
• Minimizes center liability through constant risk management review; including review of Medical Incident Reports, minor incident logs, and drives effective, timely corrective actions.
• Manages all donor incidences including donor red cell loss, over/under draws, donor reactions and behavioral issues.
• Directs donor recruitment techniques and manages customer and donor complaints.
Inventory and Sample Management
• Ensures that product shipments and sample submissions are accurate and performed in accordance with shipping schedules.
• Ensures that center is in compliance with directives on shipping listed in the DCOP and instructions provided by the corporate logistics group.
• Ensures FDA licensed product; SISPQ (strength, identity, safety, purity and quality).
• Manages product inventory within the Center with assistance of Logistics
Responsible for Supervision, Training and Development of Staff
• Trains, develops, and manages all staff in accordance with the Employee Handbook and Policy Manual, DCOP's, Training Manual and other established management guidelines and regulations.
• Hires, motivates, and evaluates center personnel based on established guidelines.
• Disciplines and terminates center employees and maintains complete, accurate personnel records.
• Ensures adequate, trained staff is available to cover the hours of operation in adherence to regulatory requirements.
• Creates an organizational environment that stimulates the morale and productivity of the work force and its leadership.
Budget and Fiscal Control
• Maintains a professional and courteous relationship with donors that will stimulate donor retention, referrals, and production growth.
• Ensures projected production budget is met in quantity, quality and within required titer requirements.
• Along with VP of Operations and/or Regional Manager, manages the Center as cost effectively as possible without sacrificing quality, to include employee time management, supply management, capital expenditures, donor fees management, etc.
JOB SPECIFICATIONS:
• Bachelor's degree in science or management related field 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 extends to a diverse group of individuals and demographics.
• Three to five years of working experience in a biomedical field preferred or a combination of advanced education and related experience.
• Ability to speak, read and write in English.
Professional appearance and demeanor.
• Ability to operate computer software including DMS (with training) and Microsoft Office.
PHYSICAL REQUIREMENTS:
• Ability to sit or stand for up to four (4) hours at a 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