25 days old

Material Management,Supervisor

Aesculap Biologics
Breinigsville, PA 18031
  • Job Code
    125398304
Aesculap Biologics


Material Management,Supervisor

US-PA-Breinigsville

Job ID: 2020-17280
Type: Regular Full-Time
# of Openings: 1
Category: Supply Chain
Aesculap Biologics LLC

Overview

Aesculap, Inc., a B. Braun company, is part of a 180-year-old global organization focused on meeting the needs of an ever-changing healthcare community. Through close collaboration with its customers, Aesculap provides advanced technologies for general surgery, neurosurgery and closure technologies. Aesculap continues a proud heritage of leadership and responsiveness as we strive to deliver products and services that improve the quality of patients lives.



Responsibilities

Position Summary:

The Materials Management (MM) Supervisor will support good manufacturing processes (GMP) Operations to coordinate and support the receipt and visual inspection of incoming cGMP and non-cGMP materials by ensuring documentation is accurate and materials are received in good condition. This position supports receipt, release, and distribution of Human Cells, Tissues, and Cellular and Tissue-Based Products (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) products are safe and effective.

Principal Duties Responsibilities:

  • This position reports to Quality Assurance, indirectly supports Manufacturing and the Quality Unit (QA/QC).
  • Operates compliant cold chain shipping logistics that include packaging, tracking, and tracing transportation of human biologic material between manufacturing facility and clinical sites within US & Canada.
  • Prepares receiving documents; documents receiving information using SAP, complies with proper handling and storage requirements of materials and components according to Aesculap Biologics Standard Operating Procedures (SOPs), and materials specifications.
  • Supports Materials Management and operations by receiving, stocking, and inventory counts, including physical counts of materials, within the SAP system.
  • Insures proper storage conditions for raw materials, semi-finished goods and final product.
  • Monitors temperatures throughout all storage areas using the REES temperature monitoring system or manual systems as needed.
  • Prepares materials for and participates in Management review activities, prepare and maintain warehouse management (WM) key performance indicators (KPIs).
  • Support MM and WM process improvement, optimization, and Project Management.
  • Initiates materials tracking through SAP to expedite supplier recalls, enable product troubleshooting, and track Human Cells, Tissues, and Cellular and Tissue-Based Products through the manufacturing process.
  • Manages inventory of raw material, semi-finished goods, finished product, 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.
  • Maintains materials management equipment in a validated state and insures that storage equipment is calibrated, cleaned, and sanitized on schedule.
  • Analyze operational issues to determine the most effective and efficient use of all resources including but not limited to analyzing inbound receiving, and inventory control procedures and proposes and/or effects changes as deemed necessary to augment/improve product / process flow.
  • Sources primary and secondary suppliers for materials and creates new material requests. This involves price comparison, contract negotiation, supplier agreement preparation. Authors and revises (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.
  • Interfaces with all levels of management and other company departments.
  • Actively contributes to the companys Quality System by participating in Risk Analysis, Change Control, and CAPA systems as required.
  • Develop and improve processes designed for operational efficiency and reducing human error.
  • Manages MSDS for materials and labels materials per OSHA requirements.
  • Ability to handle and ship biological materials according to relevant laws and company SOPs. Able to obtain IATA/HAZMAT and maintain certification thereafter.
  • Performs routine procedures following written instructions (SOPs, protocols, etc.) in support of manufacturing cell therapy product of acceptable quality to meet FDA regulatory requirements.
  • The ability to gown for performance or observation of aseptic processing in a clean room environment is required.
  • Must comply with applicable ISO and FDA regulations as stated in AB Quality Manual.
  • Must embody the Companys Vision, Mission and Values.
  • Other duties may be assigned.

Secondary or peripheral job functions:

  • Ability to work extended hours, including evenings and weekends (as needed).
  • Excellent interpersonal skills required.
  • Quick learner with good analytical skills.
  • Ability to work independently.
  • Contribute to creating a climate of trust, ethics, and accountability by effectively seeking out and accepting feedback from others.
  • Possess the ability to exceed expectations with the customer in mind and take responsibility for driving key results as well as empower others to achieve desired outcomes.
  • Demonstrate behaviors that drive efficiency by understanding and improving processes as well as sharing best practices.

Supervisory Responsibilities:

  • Carries out supervisory responsibilities in accordance with the organizations policies and applicable laws.
  • Responsibilities include interviewing, hiring, and training / development of employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.
  • Act as a lead team member in all aspects of GMP operations.
  • Development of and compliance to an annual MM Budget.


Qualifications

Expertise: Qualifications-Experience/Training/Education/Etc

Required:

  • Bachelors Degree is preferred but not required.
  • 5+ years experience in a regulated materials management (supply chain) environment.
  • Working knowledge of SAP (WM / IM) is required
  • Computer skills in MS Office; Excel, Word, and Visio is required.
  • Previous experience working in fast paced, start up environment preferred.
  • Previous experience working with a Warehouse Management System (WMS) and/or Manufacturing Execution System (MES) is a plus.
  • 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 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.

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 Equal Opportunity Employer Minorities /Women/ Veterans/Disabled

Through its Sharing Expertise initiative, B. Braun promotes best practices for continuous improvement of healthcare products and services.



All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status.

PI125398304

Categories

Posted: 2020-10-29 Expires: 2020-11-29

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Material Management,Supervisor

Aesculap Biologics
Breinigsville, PA 18031

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