Operations Manager
The Operations Manager is a key member of the donor center leadership team, responsible for overseeing day-to-day operational performance to ensure donor safety, regulatory compliance, and achievement of production goals. This role provides direct leadership to frontline staff across donor floor operations and ensures all center activities align with company standards, SOPs, and applicable regulatory requirements.
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. This position will manage employees in centers with over 50,000 liters.
Experience:
Typically requires 3+ 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.
Responsibilities:
- Responsible for all aspects of the donor center when the Center Manager is not present.
- Collaborates with Training and Quality staff to ensure that training and quality goals are met.
- Coaches and leads through effective feedback to employees through the Operations Supervisor(s).
- Monitors and evaluates operations. Works with the Center manager to develop action plans to maximize center efficiency and supervises the implementation of improvements. Makes critical decisions for the modifications of action plans.
- 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 records
- Partners with the center manager in budget preparation and oversees facility to achieve production targets and quality goals at the agreed-upon cost structure.
- Actively delegates, monitors, and holds responsible the operations supervisors for their performance.
- Directs and supervises employees. This includes creating and managing work schedules.
- Establishes and maintains the ability to perform all tasks within the center; fulfills the role of production employees when the occasional need arises.
Other Responsibilities:
- Assures 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
- Develops and implements 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).
- Directs 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).
- Builds rapport with donors to ensure overall customer satisfaction with the center to support long-term donation.
- Controls center donor funds and ensure that all financial records are accurate and in order.
- Keeps Center Manager informed of any irregularities within the center and provide action plans to improve and correct center deficiencies.
- Minimizes center liability through constant risk management review. Investigates all unsafe situations and Situations/complaints. Develops and implements required corrective actions.
- Directs and monitors the performance of outside vendors.
- Reviews and monitor special projects for accuracy and timely completion.
- Works with the Center Manager in implementing the donor center's mission into the community.
Education:
Bachelor’s degree or equivalent, preferably in Science, Business, Nursing, Finance, or related field.
KSAs:
- 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.
- May be required to relocate
Occupational Demands:
- 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.
- #BiomatUSA
