CAPS Aseptic Process Monitor

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 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.
• 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. Generate media fill summary reports with scientifically driven explanations, when applicable.
• Utilize Quality Systems (TrackWise, EDMS, etc.) to conduct thorough root cause analysis, generate nonconformance records, CAPAs , Change Control, and update procedural documents.
• Responsible for training personnel in Aseptic Techniques and processes.
• Monitor cGMP areas including but not limited to warehouse, controlled not classified (CNC) areas, and laboratories at random times to verify compliance to cGMP and CAPS SOPs including Good Documentation Practices (GDP) and data integrity of controlled forms and logbooks.
• Document shop floor monitoring activities and observations.
• Report activities and observations to site management through meetings and controlled reporting documents.
• Prepare status reports and trend metrics of observations.
• Trend Environmental Monitoring (EM) results in accordance with applicable procedures.

Responsibilities: Essential Duties

The job function listed is not exhaustive and shall also include any responsibilities as assigned by the Supervisor from time to time.

General: It shall be the duty of every employee while at work to take reasonable care for safety and health of himself/herself and other persons

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.

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

Salary Range: $67,261 - $84,076

The targeted range for this role takes into account a range of factors that are considered when making compensation and hiring decisions; included but not limited to: skill sets; experience and training; licensure and certifications; and other business and organizational needs. The disclosed range estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled. Compensation decisions are dependent on the facts and circumstances of each case. The range provided is a reasonable estimate.

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.

We are an equal opportunity employer. We evaluate applications without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, pregnancy, genetic information, disability, status as a protected veteran, or any other protected characteristic. Know Your Rights: Workplace Discrimination is Illegal, click here.

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