Manager, Biologics Procurement and Manufacturing Training - Transfusion and at Werfen GmbH

Norcross, Georgia, United States -

Full Time

Start Date

Immediate

Expiry Date

10 Feb, 26

Salary

0.0

Posted On

12 Nov, 25

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Biologics Procurement, Manufacturing Training, GMP Compliance, Quality Control, Employee Training, Inventory Management, Process Improvement, Supervisory Experience, Attention to Detail, Regulatory Training, Blood Products, Transfusion Service, Cell Culture Processes, Safety Standards, Documentation, Communication

Industry

Medical Equipment Manufacturing

Description

Overview We are looking to hire a Biologics Procurement Manager who will manage all tasks and functions associated with Biologics Procurement and Manufacturing Training. This includes managing the supply of red blood cells and other blood products needed for Werfen's Red Cell and Capture product line. This person will also manage activities associated with training new employees and cross-training or re-training current employees as needed for Red Cell Processing, Monoclonal Production, Production Support, Controlled Components, Solid Phase, Vialing and Packaging. If you’ve got the necessary skills and experience to excel in this position, we want to hear from you. Apply today! This position is not eligible for sponsorship for work authorization by Immucor, Inc. Therefore, if you will require sponsorship from us for work authorization now or in the future, we cannot consider your application at this time. Manager, Biologics Procurement and Manufacturing Training Responsibilities As the Manager, Biologics Procurement and Manufacturing Training, you will be responsible for managing the process for securing the supply of red blood cells and other blood products needed for Immucor's Red Cell and Capture product line and ensuring all products meet stringent specifications. You will ensure all new hire training and cross-training or re-training for current employees are compliant within GMP/Quality. Regulatory training areas. You will assist in the design, development, and execution of manufacturing process training for manufacturing personnel. You will support corporate expectations while maintaining compliance with GMP, Quality and Regulatory guidelines for the medical device industry. Your essential duties and responsibilities include: Ensures the continued maintenance of inventory levels for red blood cells and other blood products needed to meet production needs. Provides direct supervision, scheduling of department staff, and manages all daily activities of the departments. Ensure that the activities of each department are organized, timely, and completed according to department procedures or protocols. Ensure all departmental scheduling meets company requirements. Completes timely review of department and staff records and ensures department records are legible, complete and stored according to company procedures. Performs and documents department employee training and competency assessment in a timely manner. Make daily decisions with regard to the operations of the Biologics Procurement and Manufacturing Training department. Conduct interviews for new hires and provide feedback and evaluations for current staff including disciplinary actions when required. Maintains departmental procedure manuals and completes required reviews of SOP’s and other controlled documents as required by company policy. Maintain thorough understanding of and ensures staff adherence to all required safety standards/regulations and bio-hazardous disposal procedures in accordance with Safety and Environment regulations. Understands GMP and ISO 13485 requirements for the manufacture of in vitro Diagnostic Devices and standards relating to large scale cell culture processes for the manufacture of IVDDs. Ensures staff compliance with applicable company policies, procedures and regulatory requirements. Maintains an active commitment to continuing education (attending national, state or local meetings or completing courses) not including attending in-house education functions, and independent study sessions. Understands the source, composition, and characteristics of raw materials, components, final products and associated chemical and biosafety hazards for Red Cell and Capture Products. Understands Biologics Procurement lab processes and equipment including required maintenance, cleaning and operational procedures necessary to maintain GMP compliance. Ensures staff compliance with all company required safety practices. Responsible for the planning, development and incorporation of new and improved processes applicable to the department including deviation management. Maintains a general understanding of the activities of all company departments. Ensures the continued maintenance of neat, organized, clean departments. Maintains organized documentation and files. Interacts cooperatively and positively with co-workers and the employees of other departments and receives direction well from superiors. Employee Competency Assessment: Manage activities associated with assessing competency of incumbent employees in manufacturing on an annual basis. Responsible for documenting all competency assessments and submitting training records to L&D in a timely manner. Responsible for maintaining his/her own competency for all required processes and procedures. Manager, Biologics Procurement and Manufacturing Training Qualifications We are looking for a Manager, Biologics Procurement and Manufacturing Training, who will manage 4-6 employees, organize, schedule and supervise the daily operations of the Biologics Procurement department including Survey Production. Manager or assists in all areas of the Biologics Procurement lab, ensure appropriate completion of departmental equipment quality control, validation studies, process improvement and ongoing assessment for department trainers, assessing competence and submitting training records to L & D in a timely manner. Specific qualifications for the role include: Bachelors’ degree (BS/BA) with emphasis in Biology, Microbiology or Chemistry from four-year college or university; or equivalent combination of education and experience. Minimum 1-3 years experience in a GMP environment required. MT/CLS/Blood Bank Reference Lab/SBB preferred. 2-3 years Transfusion Service or science degree with industry experience, preferred Previous supervisory experience in manufacturing or Quality Control experience, preferred Must be available to work irregular hours including weekends and overtime as necessary to meet company requirements and production demands. May be required to cover additional responsibilities and/or provide consultation and/or assistance in "off-hours". Experience with extended red cell antigens and their characteristics, preferred Strong attention to detail and ability to summarize and communicate at all levels of the organization. Experience with Excel, SharePoint, Outlook, preferred Facilitation experience Manager, Biologics Procurement and Manufacturing Training

Responsibilities

Manage the supply of red blood cells and other blood products for Immucor's product line while ensuring compliance with GMP and regulatory guidelines. Oversee training for new and existing employees in various manufacturing processes and maintain departmental operations.