CAPS Aseptic Process Monitor

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:

• Complete daily visual audits of aseptic behavior inside the cleanroom during set up, filling, tear down, and sanitization processes.
• Communicate openly to all personnel in the cleanroom to provide real time feedback and mentoring regarding observed aseptic performance.
• Take immediate corrective and preventative action when non-compliance and/or undesired behavior by personnel in the facility is observed.
• Provide corrective action training based on visual audits by providing immediate feedback.
• Partner with Operations/Quality/Training Leadership to make recommendations for enhancements to aseptic processes and completion of required trainings.
• Review aseptic technique associated with media fills and help complete documentation and final vial count verification as necessary.
• Perform other essential quality functions including, but not limited to: release of cleaning agents, release of raw materials, and line clearance
• Responsible for training personnel in Aseptic Techniques and processes.

Responsibilities: Essential Duties

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.

• Works under general supervision. Relies on experience and judgement to plan and accomplish assigned goals. May periodically assist in orienting, training, and/or reviewing the work of other 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.

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Expertise: Qualifications -Education/Experience/Training/Etc

Required:

• Bachelor's degree required.
• 04-06 years related experience required.
• cGMP experience/training required, Aseptic processing training/experience required

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: N/A
• Frequently: Push/pull, Stand, Sit
• Constantly: N/A

Activities:

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

Equal Opportunity Employer Veterans/Disabled

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