B. Braun

QC Microbiology Assoc IV, Sterilization Assurance

Job Locations US-CA-Irvine
Requisition ID
B. Braun Medical Inc
# of Openings
Position Type
Regular Full-Time
8:00am - 4:30pm
Irvine, CA


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.


Position Summary:

Performs advanced and sometimes routine functions and analysis (dependent upon experience) as required by the specific laboratory requirement in compliance with B. Braun and cGMP specifications.


Responsibilities: Essential Duties

  • Collects and reviews Sterilization Bar Code Accountability and Packing Sterilizer Tag Verification/ Accountability for accuracy and completeness.
  • Collects, sorts and verifies Sterilization Tags for accuracy and completeness.
  • Collects Split Load Verification Forms (SLVF)s, Quality Control Sterilization Release Checklist, Product/ Process Deviation Reports (PPDR)s, Event Report Forms (ERF)s, Equipment Failure Reports (EFR)s Quality Control Reports (QCR)s, Quality Control Investigations (QCI)s, and review them for accuracy and completeness.
  • Reviews sterilization cycle data and generates Sterilizer Load Reports (SLR)s from the PLC sterilizer control system.
  • Sorts SLRs and QCRs/QCIs for deviations
  • Records Sterilization information on the SLVFs.
  • Generates QCRs and data dump from the SMS system.
  • Uploads and reviews SLR, QCR and/or Foxboro report in the MES Electronic Batch Record (EBR) system for accuracy and completeness.
  • Reviews and/or approves SLRs, QCRs and Foxboro report for product related, Production Test Run Authorization (PTRA), and Engineering Test Run (ETR) for accuracy and completeness.
  • Familiarity with Sterilization Bar Code system (SBC), Production Specification System (PSS), Sterilization Verification System (SVS).
  • Initiates Discrepancy Management System (DSMS) from SAP system
  • Performs Manual Release per appropriate procedure.
  • Coordinates activities with Sterilization Production and Maintenance to resolve process deviations. Investigates deviations during steam sterilization process for PPDRs/ DSMSs.
  • Keeps track of PPDRs, DSMSs and ERFs.
  • Prepares formal report of the sterilization PPDRs and DSMSs for management review.
  • Updates and revises sterilization procedures as needed.
  • Obtains GMP Qualified Trainer.
  • Intensive knowledge of Steam Sterilization Process.
  • Reviews sterilization related deviations, initiate failure investigations, and recommends disposition of nonconforming lots

Expertise: Knowledge & Skills

  • Become proficient in environmental monitoring techniques specific to Microbiology.
  • Become proficient in finished product and raw material testing as required, i.e. Sterility, LAL, Bioburden and Electronic PM.
  • Learn to write and edit environmental monitoring and laboratory procedures dependant upon experience.
  • Become proficient in Microbial techniques such as Gram staining, dilutions, filtering, and evaluation of plates and test tubes for microbial growth.
  • Initiate and/or conduct the investigation for non-conformance of routine testing specifications dependant upon experience.
  • Understanding of aseptic laboratory and manufacturing processes
  • Knowledge in CFR, USP, cGMP, GLP, and other FDA regulations
  • Knowledge and experience in microbiology and sterilization validations
  • Knowledge in project management
  • Ability to use Microsoft Office (Word, Access, PowerPoint, Excel)
  • Excellent verbal and written communication skills
  • Excellent organizational skills with the ability to adapt to changes
  • Knowledge of LIMS


Expertise: Qualifications - Experience/Training/Education/Etc


  • BS degree in Microbiology or related field
  • 4 – 5 years lab experience in Pharmaceutical or Medical Device Industry


  • Working knowledge and/or experience in Aseptic Processing Manufacturing
  • Working knowledge and/or experience in Aseptic Processing Validation (Media Fills)
  • Working knowledge and/or experience with Isolator Technology

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.


Responsibilities: Other Duties:

  • Other duties as assigned.

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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