Quality Systems Specialist II - Computer Systems

Company: B. Braun
Location: Allentown
Posted on: January 23, 2023

Job Description:

About B. Braun - -B. Braun Medical Inc., a leader in infusion therapy and pain management, develops, manufactures, and markets innovative medical products and services to the healthcare industry. Other key product areas include nutrition, pharmacy admixture and compounding, ostomy and wound care, and dialysis. The company is committed to eliminating preventable treatment errors and enhancing patient, clinician and environmental safety. B. Braun Medical is headquartered in Bethlehem, Pa., and is part of the B. Braun Group of Companies in the U.S., which includes B. Braun Interventional Systems, Aesculap - and CAPS -. -Globally, the B. Braun Group of Companies employs more than 64,000 employees in 64 countries. Guided by its Sharing Expertise - philosophy, B. Braun continuously exchanges knowledge with customers, partners and clinicians to address the critical issues of improving care and lowering costs. To learn more about B. Braun Medical, visit .Position Summary: - - -Responsibilities: Essential Duties

• Establishes guidelines for computer system validation and oversees the computer and controls validation program for B. Braun U.S. to ensure compliance with FDA requirements.
• Responsible for establishing standardized and harmonized core quality systems and processes for B. Braun Medical Inc. (BBMI) that are compliant, efficient and effective and employ best practices in industry. Focus will be on core computer systems such as SAP C3, QM, CAPA/Complaints/Deviations/Discrepancies, LabWare, LIMS, Laboratory Instruments, Management of Change, Validation, and Auditing.
• Interfaces with all BBMI sites to ensure core quality systems and processes are properly implemented and maintained for sustained compliance.
• Ensures quality and regulatory compliance requirements are identified, documented, integrated, and maintained to avoid gaps and ineffectiveness. Supports Data Integrity (DI) lab remediation activities for all sites.
• Supervises and otherwise manages personnel and contractors involved in computer and control system validation.
• Provides technical guidance and supervision to B. Braun U.S. computer system validation engineers and Global Operations at multiple B. Braun U.S. facilities.
• Implements and maintains the Corporate Operating Procedures and centralized processes and templates, identifies and implements process improvement tools for Quality Systems to ensure the process requirements of Quality Compliance systems integrated.
• Understands the efficiencies and criticalities of all of the quality systems elements at BBMI. -Works seamlessly with functional business groups to improve upon vertical and horizontal system interfaces and efficiencies.
• Executes the strategic direction for Quality Systems Excellence Programs & Deployment Management. Understands quality and regulatory requirements and integrates these within the company's Quality Management System in accordance with system capabilities. -Evaluates and implements system and process improvements to ensure that quality systems continue to meet regulatory requirements and expectations. - -
• Reviews regulatory rules and guidelines pertaining to computer systems and electronic data and determine their impact on B. Braun U.S. operations. -Stays current with FDA requirements for these rules. -The job function listed is not exhaustive and shall also include any responsibilities as assigned b" -Expertise: Knowledge & Skills
  • Requires full working knowledge of relevant business practices and procedures in professional field. Uses standard theories, principles and concepts and integrates them to propose a course of action.
  • Work under minimal supervision. Relies on experience and judgement to plan and accomplish assigned goals. May periodically assist in orienting, training, and/or reviewing the work of peers.
  • Judgement is required in resolving complex problems based on experience.
  • Contacts are primarily with department supervisors, leads, subordinates, and peers. Occasional contact with external contractors/vendors. -81900-102400Expertise: Qualifications -Education/Experience/Training/Etc -Required:
    • Bachelor's degree required.
    • 06-08 years related experience required.
    • Applicable industry/professional certification preferred.
    • Regular and predictable attendance
    • Occasional business travel required, Valid driver's license and passport -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 20 pounds. - - -. -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. -Physical Demands:While performing the duties of this job, the employee is expected to:
      • Moderate work - Exerting up to 40 lbs of force occasionally, and/or up to 20 lbs of force frequently, and/or 10 lbs force constantly to move objects.Lifting, Carrying, Pushing, Pulling and Reaching:
        • Occasionally:Reaching upward and downward, Push/pull, Stand, Visual Acuity with or without corrective lenses
        • Frequently:Sit
        • Constantly:N/AActivities:
          • Occasionally:Finger feeling, Push/pull, Reaching upward and downward, Seeing - depth perception, color vision, field of vision/peripheral, Standing, Walking
          • Frequently:Hearing - ordinary, fine distinction, loud (hearing protection required), Sitting , Talking - ordinary, loud/quick
          • Constantly:N/AEnvironmental Conditions:
            • Occasionally:Proximity to moving parts
            • Frequently:N/A
            • Constantly:N/A Work Environment: -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.
              • Noise Intensity:Moderate
              • Occasionally:Production/manufacturing environment, Lab environment, Other
              • Frequently:Office environment
              • Constantly:N/A -B. 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.Equal Opportunity Employer Veterans/Disabled

Keywords: B. Braun, Allentown , Quality Systems Specialist II - Computer Systems, Other , Allentown, Pennsylvania