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 61,000 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 www.BBraunUSA.com.

Position Summary:

 

Responsibilities: Essential Duties

• Responsible for the implementation and continuous improvement of the Site Data Integrity Program.
• Maintains comprehensive knowledge of applicable data integrity quality and regulatory requirements,including 21 CFR Part 11.
• Identifies data integrity compliance risks and gaps across the site, communicates those risks to Site.
• Management and develops and implements effective and efficient solutions to address those gaps.
• Coordinates the site's quality, security and maintenance of laboratory and production data, therefore ensuring compliant data can effectively support the business process.
• Create data process mapping and risk reduction efforts for data owners and Quality representatives.
• Defines data elements and establishes policies and procedures related to the collection and accuracy of data, and performs tests and audits on data systems.
• Ensures sufficient data quality is maintained so that the data can effective support the business process. -
• Provides expertise of data, data management and data to moderately complex aspects of a project.
• Creates methodologies and metrics for tracking performance to required Data Integrity expectations and objectives.

 

 

Expertise: Knowledge & Skills

• Requires advanced knowledge of professional field and industry. Influences the development of and drives the application of principles, theories, concepts. Determines best 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. Frequent contact with external contractors/vendors.

$95,615 - $119,511

Expertise: Qualifications -Education/Experience/Training/Etc

 

Required:

• Bachelor's degree required.

• 04-06 years related experience required.

• 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:

• Light work - Exerting up to 20 lbs of force occasionally, and/or up to 10 pounds of force frequently, and/or a negligible amount of force constantly to move objects.

Lifting, Carrying, Pushing, Pulling and Reaching:

• Occasionally:Reaching upward and downward, Push/pull, Stand
• Frequently:Stand,Sit
• Constantly:N/A

Activities:

• Occasionally: Push/pull, Reaching upward and downward, Standing, Walking
• Frequently:Finger feeling, Hearing - ordinary, fine distinction, loud (hearing protection required), Seeing - depth perception, color vision, field of vision/peripheral, Sitting , Talking - ordinary, loud/quick
• Constantly:N/A

Environmental Conditions:

• Occasionally:N/A
• 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: Low
• Occasionally: Production/manufacturing environment
• Frequently:N/A
• Constantly:Office environment

 

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