B. Braun

Product Release Analyst- Documentation Asst.

Job Locations US-CA-Irvine
Requisition ID
2018-11679
Company
B. Braun Medical Inc
# of Openings
2
Category
Manufacturing
Position Type
Regular Full-Time
Shift
8:00am-4:30pm
Site
Irvine, CA

Overview

With a nationwide sales team and several manufacturing locations, B. Braun Medical has become a leading full-line supplier of healthcare products and services in the U.S. The company is committed to delivering innovative products and services with unmatched quality, superior technology, and cost-effectiveness, while maintaining environmental responsibility. Through its "Sharing Expertise®" initiative, B. Braun promotes best practices for continuous improvement of healthcare products and services. B. Braun employs over 4,500 people in the USA. B. Braun Medical Inc. began its operations in the USA in 1957. Initially, the company manufactured and sold disposable plastic syringes. During the 1980s and early 1990s, the company undertook several expansions and enlarged its product line of disposable medical devices. With the acquisition of McGaw, Inc. in 1997, including Central Admixture Pharmacy Services, Inc. (CAPS®), B. Braun dramatically broadened its product lines and services to U.S. customers.

 

U.S. Facilities and Operations:

 

Supporting product sales are a network of nationwide marketing and manufacturing locations. Bethlehem, Pennsylvania, is home to the U.S. Corporate Headquarters along with the marketing offices of the Hospital, Outpatient Markets (OPM), Renal Therapies, Vascular Interventional, International, and OEM Divisions. Central Admixture Pharmacy Services, Inc.(CAPS®) is also managed from this location. The nearby Allentown, Pennsylvania, facility manufactures Needle-free products, IV Safety Catheters, Anesthesia Systems, Introducers, Pharmacy Admixture products. Vascular products including Right Heart Catheters and Interventional Accessories are also manufactured in Allentown. The Irvine, California facility produces IV Solutions, Basic and Specialty Nutrition, Drug Delivery, and BTC products. Infusion Pump Systems are manufactured in Carrollton, Texas and IV administration and IV and Irrigation sets are produced in the Dominican Republic.

Responsibilities

Position Summary:


Document, coordinate and enter into computer systems all of the elements required to manufacture B. Braun products and maintain compliance to Quality Systems.

Responsibilities: Essential Duties

  • Maintain the official Bills of Materials (BOMs) for all B. Braun manufactured products including the history files of all changes. This includes Master Production and Control files approval and history files.
  • Update SAP through entry of new/revised product drawing levels and input of SOPs for BOMs to support the Procedures/drawing cross-reference.
  • Maintain BDocs for all new and revised SOPs by processing In-box documents to Effective. This includes coordinating Early Effective requests, QA Doc final review along with confirming multiple SOPs to implement on the same date driven by various Project requirements.
  • Coordinate with Drafting and Engineering for the generation and issuance of New/Revised product drawings. This includes reviewing all Drafting work for final issuance and maintain the history files of all Document Order (DO), marked up copies, and approval records.
  • Coordinate the implementation of approved LINs (Label Input Notifications) for packaging specifications and labeling part numbers. This includes updating the part number in the BOMs and maintaining drawing cross-reference for the parts.
  • Support the hard copy distribution of all updated documents for the Disaster Recover Manuals.
  • Coordinate GMP documentation archival and retrieval from Iron Mountain Storage services.
  • Issue Controlled Notebooks
  • Issue Batch Records and Controlled Data Sheets on controlled colored paper.
  • Issue PTRA numbers
  • Process Finished Product Release activities to include final disposition. This includes accurate and timely daily updates regarding each batch’s status. Additionally, batch file maintenance, SAP release transaction once confirmation of accurate inventory is determined, along with follow-up on overdue lab results are included.
  • Secure Validation holds for finished product prior to finalization of successful PQ/PV or CBE-30 is achieved.
  • Support scanning and uploading data into electronic batch records (EBR) and Discrepancy Management System (DSMS)
  • Generate Certificate of Analysis.

Expertise: Knowledge & Skills

  • Knowledge of B. Braun manufacturing processes and documentation is highly desirable.
  • Knowledge of Quality System requirements and quality standards
  • Working knowledge of SAP
  • Working knowledge of BDocs
  • Microsoft Word, Access and Excel
  • Good written and verbal communication skills.
  • Ability to organize and prioritize work.
  • Ability to meet deadlines and work under pressure
  • Proficient in the use of personal and basic software.
  • Ability to work independently.
  • Interpersonal skills to work with various departments and different management levels.

Qualifications

Expertise: Qualifications - Experience/Training/Education/Etc


Required:

  • High School Diploma and 3 – 4 years related experience

Desired:

  • AA in Management/Administration or two years of business school/college.
  • Three years of experience in technical writing or administration of multi-departmental documentation and computerized reference systems.

 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.

 

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 Equal Opportunity Employer Minorities /Women/ Veterans/Disabled.

Through its “Sharing Expertise®” initiative, B. Braun promotes best practices for continuous improvement of healthcare products and services. 

Other

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:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

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. The noise level in the work environment is usually moderate.

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