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Tuscaloosa

    Center Manager - Tuscaloosa, United States - BPL Plasma

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    Description

    **Position** : Center Manager

    **Location** : Tuscaloosa, AL

    Duties and Responsibilities:

    1. 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.

    2. 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.

    3. 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.

    4. 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.

    5. 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.

    All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status.


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