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
Didn't find what you're looking for? Search again!
Loading more jobs...