Biotest Pharmaceutical Corporation Job - 31461175 | CareerArc
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Company: Biotest Pharmaceutical Corporation
Location: Hinesville, GA
Career Level: Mid-Senior Level
Industries: Healthcare, Pharmaceutical, Biotech

Description

Summary: Assists with operational management of a Plasma Collection Center, ensuring compliance with all applicable policies and regulations and overall performance and profitability of the center. Acts on behalf of the Center Manager in his/her absence, may manage the center alone for days at a time.

Primary Responsibilities for role:
● Partners with the center manager in budget preparation and oversees facility to achieve production targets and quality goals at the agreed-upon cost structure.
● Review and approve employee schedules to accommodate donor cycles.
● Actively delegates, monitors and holds responsible the operations supervisors for their performance.
● Directs and supervises employees.


Other Responsibilities for role:
● Responsible for all personnel functions including hiring, assignment and direction of work, development and training, disciplinary actions and termination and the maintenance of all personnel
● Directs the training activities of production employees through the Training Coordinator.
● Determine the adequacy and adjust inventory levels of all goods and supplies necessary of the operation of the donor center. Compile and submit orders to vendors to meet determined inventory
● Assure center employees maintain the facility in a neat and clean condition and all equipment is kept in good working order.
● Responsible for freezer management, including overseeing plasma shipments and equipment failures. Required to answer all freezer alarms and deal with them appropriately.
● Control center donor funds and ensure that all financial records are accurate and in order.
● Creates appropriate organizational environment and value systems which stimulate the morale and productivity of the work force and its leadership.
● Responsible for all aspects of the donor center when the Center Manager is not present.
● Construct and submit timely and accurate reports on a daily/weekly/monthly or as required basis.
● Develop and implement active donor recruitment advertising campaigns to improve production levels.
● Maintains thorough familiarity and ensures compliance with state and federal regulations, U.S. Food and Drug Administration (FDA)-approved Standard Operating Procedures, Occupational Safety and Health Administration (OSHA), Clinical Laboratory Improvement Amendments (CLIA), and Current Good Manufacturing Practice (cGMP)
● Direct key personnel in donor selection, plasma collection and all manufacturing records to maintain the highest production standards in accordance with state and federal regulations, U.S. Food and Drug Administration (FDA)-approved Standard Operating Procedures, Occupational Safety and Health Administration (OSHA), Clinical Laboratory Improvement Amendments (CLIA), and Current Good Manufacturing Practice (cGMP).
● Works with the Center Manager in implementing the donor center's mission into the community.



Qualifications

Knowledge, Skills, and Abilities: Developing command of leadership, organizational, customer service, interpersonal communication, and computer abilities. Ability to understand and assess FDA regulations. Ability to maintain adequate levels of plasma collection and adhere to quality standards. Ability to motivate staff to achieve established goals and standards.


Education: Bachelor's degree or equivalent, preferably in Science, Business, Nursing, Finance, or related field.


Experience: Typically requires 2 years of related experience in clinical or general business experience. Supervisory experience preferred. Experience in a medical and/or cGMP regulated environment preferred. Experience with plasma or whole blood preferred.


Equivalency: Depending on the area of assignment, directly related experience or a combination of directly related education and experience and/or competencies may be considered in place of the stated requirements. Example: If a job level requires a Bachelor's degree plus 4 years of experience, an equivalency could include 8 years of experience, an Associate's degree with 6 years of experience, or a Master's degree with 2 years of experience.

Occupational Demands: Occupational Demands Form # 6: Work is performed in an office and/or a laboratory/manufacturing environment. Exposure to biological fluids with potential exposure to infectious organisms. Exposure to electrical office equipment. Exposure to extreme cold below 32*, miscellaneous production chemicals, moving machinery and production equipment. Exposure to high levels of noise on production floor. Personal protective equipment required such as protective eyewear, garments and gloves. Frequently sits for 6-8 hours per day. Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists. Occasionally walks. Occasionally bends and twists neck. Light to moderate lifting and carrying objects with a maximum lift of 35lbs. Frequently drives to site locations with occasional travel within the United States. Able to communicate complex information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences. Works independently with little guidance or reliance on oral or written instructions and plans work schedules to meet goals.Frequently interacts with others, relates sensitive information to diverse groups. Must work with diverse groups to obtain consensus on issues. Ability to apply abstract principles to solve complex conceptual issues.


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