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Center Manager - Mission, United States - BPL Plasma
Description
**Position** : Center Manager
**Location** : Palmview, TX
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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