Supervisory responsibility of Center Directors for development, production, cost, and operations in assigned Donor Centers. Actively participates and directly responsible for maintaining a quality facility.
Essential Job Functions
Operations and Development
In conjunction with the Regional Director of Operations, support the company goals through the professional development of center management and employees.
Assist in the development and implementation of processes designed to facilitate continued quality operations at the center level.
Develop, integrate, streamline, and simplify center operations, with consideration of the impact of quality and compliance.
Assist in the identification, evaluation, and hiring of candidates for available positions.
Assist RA/QA in the development and integration of new/revised SOP's. Report status of assigned centers to Regional Director in a timely manner and consistent manner.
Submit timely n accurate reports as necessary.
Communicate/partner with the Center Director and Quality Manger to assure assigned donor centers continuously meet regulatory, customer, and SOP requirements.
Assist in budget preparation for designated centers and ensure facilities operate within the agreed-upon budget.
Center Support and Development
Provide strategic direction, planning, and customer focus to assigned center management.
Responsible for the evaluation and determination of an employee's competence to perform required job function throughout the development process and with periodic employee observations.
Provide Guidance and assistance to assigned center to ensure achievement of weekly, monthly, and annual production and profit targets. This includes, but is not limited to, assistance in developing effective donor and employee recruitment campaigns and performing impact analysis on proposed wage and donor fee changes.
Continuously monitor and evaluate operations and development at assigned centers and provide feedback including, but not limited to, suggestions for changes and assistance in implementing the changes.
Develop skills of assigned Center Directors and other center staff.
Review and approve supply orders (including office, medical, soft goods and other items) for assigned centers ensuring compliance with budgeted targets.
Establish and maintain ability to perform any/all tasks associated with the Center Director position to fulfill role if need arises.
Perform periodic operational audits of each assigned center to ensure compliance with company policies. May also be responsible for conducting compliance audits of center is in compliance with customer requirements.
Maintain thorough familiarity with State and Federal regulations, FDA approved Standard Operating Procedure manual, OSHA, CUA, cGMP, and customer requirements.
Assure compliance with SOPs upon implementation.
Keep immediate supervisor informed of any irregularities within the center and provide constructive information about process improvement.
Minimize center liability through constant risk management review.
Additional Duties and Responsibilities
May be assigned to develop and work with new employees at all levels.
May be assigned to assist in other areas needed.
Supervises all designated Center Directors as specified by the Regional Director.
Carries out supervisory responsibilities in accordance with the organizations policies and applicable laws. Responsibilities include interviewing, hiring, and developing employees; planning, assigning, and directing work; appraising performance; rewarding and discipline employees, addressing, complaints, and resolving problems.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Education and/or Experience
College degree preferred. Minimum three (3) years' experience in biologics/plasma center operations and/or FDA regulated enterprise required. Previous experience should demonstrate expertise in plasma center operations, understanding of plasma center cost models and components, performance of operational analysis /audits, as well as an understanding of quality control principals, cGMPS, FDA regulations and SOP implementation.
Strong organizational, interpersonal, written and verbal communication skills required. Demonstrate self-motivated ability and be able to work with minimal supervision. Must be able to write legibly. Must be able to use PC effectively and be capable of working with Word and Excel documents. Must be able to travel 75% to 100% of the time as required.
Ability to read and interpret documents such as safety rules, operating and maintenance instruction, procedure and technical manuals. Ability to write routine reports and correspondence. Ability to speak effectively before groups of customers or employees of the organization.
Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.
Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is regularly required to use hands and fingers, handle, or feel objects, tools, or control; reach with hands and arms; and talk or hear. The employee frequently is required to stand, walk, climb, or balance; and stoop, kneel, crouch, or crawl.
Ability to travel via automobile and/or airplane. Able to stand for extended periods of time-up to four (4) hours at a time. Capable of viewing a video display terminal less than 18" away from face up to four (4) hours at a time. Must be able to lift, tug, and pull up to fifty (50) pounds.
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
The noise level in the work environment I usually moderate. May be exposed to short periods of time to freezing temperatures. Occupational exposure to blood-borne pathogens.