Provide leadership and management to all aspects of Manufacturing which includes all processes from receipt of unprocessed blood through shipment of finished goods. Ensure coordination among various departments for the processing and distribution of blood products. Manage customer demands with production inventory and delivery of products to meet customer demand.
Perform all Manufacturing duties and responsibilities in compliance with standard operating procedures, Safety Quality Identity Potency Purity (SQUIPP), regulations outlined in the Code of Federal Regulations (CFR), Occupational Safety and Health Administration (OSHA) and other applicable Federal, state and local regulations
1. Responsible for the direction of Manufacturing staff including, but not limited to, hiring, training, coaching, evaluating and disciplining to ensure a well-qualified team and to enhance operational success and compliance.
2. Responsible for effective Manufacturing. Ensure all functions are performed in accordance with all applicable regulations, policies and/or procedures (CFR, BSD, LOP, etc.) and in a timely fashion concurrent to customer needs.
3. Responsible for Quality Assurance and Regulatory Compliance programs for Manufacturing.
4. Responsible for operational compliance, employee, fiscal, asset and operational management. Provide staffing, planning, organization, and leadership to, and management of, all Manufacturing services.
5. Ensure creation of a cGMP culture within assigned units.
6. Ensure that products produced are consistent with product demand. Responsible for accurate systems and strategies, effective collaboration with Donor Services, Donor Management, Inventory Management, and National Testing labs.
7. Evaluate manufacturing processes to ensure efficient and streamlined processes.
8. Ensure that employees in assigned units are competent, trained, and adhere to all company, local, state and federal requirements.
9. Perform other duties as necessary.
The above statements are intended to describe the general nature and level of work being performed. They are not intended to be an exhaustive list of all responsibilities and duties required of staff so classified.
Accountable for prudent development and expenditure of total departmental operating budgets; recommends capital expenditures as needed. Operate under general guidelines from senior management. Oversee planning process and ensure that long range goals are established for laboratory supervisory staff. Plan own work and set priorities for department. Actions and decisions based on very broad precedent, discretion and judgment.
Supervisory responsibility for multiple staff levels, including supervisors, professional staff and line staff.
• Bachelor's Degree in applied sciences, Biology, Nursing, MT (ASCP) or equivalent combination of education and relevant experience required.
• Minimum seven years related experience including five years management experience required.
• Relevant experience includes work in technical blood banking, laboratory or a pharmaceutical manufacturing facility.
• Masters Degree preferred, Excellent communications and interpersonal skills required
Essential Functions/Physical Requirements
The duties are representative of the essential functions of the position. Operational flexibility is required to meet sudden and unpredictable needs.
Exposure levels are based on the essential functions as stated in this position description; however, in some instances, variances may occur due to the applicable nature of this position within a particular work site.
Therefore the work site may determine the exposure level to be greater than or less than the below stated level.
This position is an exposure determination 2 in view of the fact that the incumbent occasionally, on an unplanned basis, is required to work under conditions where the potential exists for the incumbent to make contact with blood or blood components and/or human body fluids or tissue samples as a result of splashes, spills, and/or needle sticks.
The American Red Cross is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.
The American Red Cross is a diverse nonprofit organization offering its employee’s professional development and growth opportunities, a competitive salary, comprehensive benefits, and a collaborative team spirit environment. To be considered for this position, please visit www.redcross.org/jobs to apply.
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