Aesculap BiologicsRequisition ID 2019-14144Company Aesculap Biologics# of Openings 1Job Locations US-PA-BreinigsvilleCategory OtherPosition Type Regular Full-TimeShift 8 am to 5 pmSite Aesculap BiologicsOverview
Aesculap Biologics, LLC, was established in January 2012 as a division of Aesculap, Inc. and is focused on biological approaches to the repair and regeneration of diseased or damaged tissues. Using a combination of cells, growth factors and smart biomaterial devices, Aesculap Biologics products can stimulate and support the synthesis of new tissue and enhance the body's own regenerative power to improve the quality of patients lives.
The Sr. Materials Management Associate will support GMP Operations to coordinate and support the procurement and/or receipt and visual inspection of incoming cGMP and non-cGMP materials by ensuring documentation is accurate and materials are received in good condition. They will also be responsible for assisting Manufacturing and Quality Management staff in support activities for cGxP manufacturing such as maintenance of equipment files, supplier quality management files, and quality records maintenance. This position supports procurement of materials and/or release and distribution as well as well as the receipt and shipping of HCT/P and therefore has an indirect impact on patient safety. All job functions must be carried out responsibly, competently and conscientiously to ensure that Aesculap Biologics' (AB) and Aesculap Implant Systems (AIS) products are safe and effective.
Responsibilities: Essential Duties
- This position reports to the MM Supervisor but also directly supports Manufacturing and Quality Management. This role will also support various supply chain activities for Aesculap Implant Systems.
- Sources primary and secondary suppliers for materials and creates new material requests. This involves price comparison, contract negotiation, supplier agreement preparation. May participate in Supplier Qualification and Quality Agreement processes.
- Creates and manages purchase order process and procurement activities to support raw material, consumable, and vendor service sourcing.
- Utilizes Material Requirements Planning (MRP) within SAP to create purchase orders and purchase requests as necessary to meet AB/AIS operational needs.
- Ensures purchasing information is accurate and up to date for all vendors and materials to ensure the accuracy of all purchase orders.
- Initiates materials tracking through SAP to expedite supplier recalls, enable product troubleshooting, and track HCT/Ps through the manufacturing process.
- Authors and revises Standard Operating Procedures (SOPs) and protocols for materials management and shipping in compliance with the cGMP/GTP. May author and revise other SOPs as required. Trains staff to relevant procedures.
- Work with the Legal Department to determine and put in place a Supply/Licensing/Quality Agreement when needed for certain materials.
- Prepares receiving documents; routes receiving information using SAP or hard copy documents; complies with proper handling and storage requirements of materials and components according to Aesculap's SOPs, materials' specifications, and SAP.
- Analyze operational issues to determine the most effective and efficient use of all resources including but not limited to analyzing procurement, inbound receiving, and inventory control procedures and proposes and/or effects changes as deemed necessary to augment/improve product flow.
- Creates, revises, and maintains SAP Production Planning (BOM, routing), MRP, Warehouse / Inventory Management, and Quality Management master data to support AB operations.
- Manages inventory of commodities and expired materials to meet financial objectives and optimize company assets.
- Ensures accurate and complete records are kept regarding consumption, cost, selling price, stock levels and other data.
- Coordinates and resolves with accounting and the vendor any invoicing, receiving and credit problems.
- Interfaces with all levels of management and other company departments.
- Actively contributes to the company's Quality System by participating in Risk Analysis and CAPA systems as required.
- Develop and improve processes designed for operational efficiency and reducing human error.
- Responsible for material lifecycle maintenance; new material selection, SAP material creation, material master maintenance, and material phase out/obsolesence.
- Manages MSDS for materials and labels materials per OSHA requirements.
- Determines appropriate actions for rejected materials and coordinates final disposition with the vendor and Quality Management.
- Performs routine procedures following written instructions (SOPs, protocols, etc.) in support of manufacturing cell therapy product of acceptable quality to meet FDA regulatory requirements.
- Ability to be gowning certified for cleanroom work as needed within 3 months of hire and semi-annually thereafter.
- Must comply with applicable ISO and FDA regulations as stated in Quality Manual
- Must embody the Company's Vision, Mission and Values
- Other duties may be assigned
Expertise: Knowledge & Skills
Secondary or peripheral job functions:
- Ability to work extended hours, including evenings and weekends.
- Excellent interpersonal skills required.
- Quick learner with good analytical skills.
- Ability to work independently.
- This position includes exposure to potentially contaminated biologic materials, instruments and blood or other bodily fluids. In compliance with OSHA regulations, Aesculap will provide required training and a safe working environment for all employees.
- Bachelors Degree is preferred but not required.
- 4-6 years experience in a GMP materials management environment.
- Previous experience working in fast paced, start up environment preferred.
- MS Word and Excel software experience required.
- Previous experience working with a Warehouse Management System (WMS) and/or Manufacturing Execution System (MES) required.
- Working knowledge of SAP ERP required.
- APICS certification is a plus.
- Language and mathematical skills; reasoning ability:
- Language Skills: Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals. Ability to write routine reports and correspondence. Ability to speak effectively before groups of customers or employees of organization.
- Mathematical Skills: Ability to add, subtract, multiply, divide in all units of measure, using whole numbers, common fractions, and decimals. Ability to compute rate, ratio, and percent and to draw and interpret bar graphs.
- Reasoning Ability: Ability to define problems, collect date, 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.
While performing the duties of this job, the employee is regularly required to sit and talk or hear. The employee frequently is required to use hands to handle or feel and reach with hands and arms. The employee is occasionally required to stand and walk. The employee must occasionally lift and/or move up to 50 pounds.
Braun offers an excellent benefits package, which includes healthcare, a 401(k) plan, and tuition reimbursement. To learn more about B. Braun and our safety healthcare products or view a listing of our employment opportunities, please visit us on the internet at www.bbraunusa.com.
Through its \"Sharing Expertise--\" initiative, B. Braun promotes best practices for continuous improvement of healthcare products and services.
Responsibilities: Other Duties:
The preceding functions have been provided as examples of the types of work performed by employees assigned to this position. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed in this description are representative of the knowledge, skill, and/or ability required. Management reserves the right to add, modify, change or rescind the work assignments of different positions due to reasonable accommodation or other reasons.
- While performing the duties of this job, the employee is regularly required to sit and talk or hear. The employee frequently is required to use hands to finger, handle, or feel and reach with hands and arms. The employee is occasionally required to stand and walk. The employee must occasionally lift and/or move up to 50 pounds.
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.
- This position could require the handling of instruments that may or may not have been contaminated by blood or other body fluids. In compliance with Occupational Safety and Health Administration (OSHA) regulations, Aesculap will provide a safe working environment for all employees. The noise level in the work environment is usually moderate.
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.