B. Braun

Manager II, QC Environmental Monitoring

Job Locations US-CA-Irvine
Requisition ID
2020-17019
Company
B. Braun Medical Inc
# of Openings
1
Category
Quality
Position Type
Regular Full-Time
Shift
M-F: 8am - 5pm
Site
Irvine, CA

Overview

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.

Responsibilities

Position Summary:

The Manager, QC Microbiology has primary responsibilities for supporting, planning, managing, and executing the daily, short term and long term activities and goals associated with environmental monitoring, including but not limited to Cleanroom and personnel monitoring, Utility system monitoring (compressed gases and water systems),  as well as project based production support within the Quality team.  Serve as the site Subject Matter Expert on site contamination control strategies related to environmental and personnel controls, cleanroom cleaning and disinfection and HVAC performance qualification (EMPQ) validation, related sample collection and testing methodology and regulatory compliance requirements for pharmaceutical manufacturing.  Interact with FDA and other regulatory authorities as Subject Matter Expert for the site Environmental Monitoring Program and Contamination Control Strategy.  Manage the development and implementation of related programs to maximize efficiencies of staff, testing and budgetary resources necessary to support the company goals while complying with regulatory requirements and expectations. 

 

 

Responsibilities: Essential Duties

 

  • Manages the quality control activities assigned to the Environmental Monitoring organization.
  • Knowledge of EM programs associated with sterile products produced by terminal sterilization processes.
  • Assists with overseeing tasks associated with releasing cleanrooms back into production after plant shutdowns.
  • Ensures that EM data meets quality standards and develops corrective action when needed.
  • Develops, implements and assesses processes and policies designed to assess performance of the systems monitored under the EM program.
  • Monitors and evaluates current sample collection and testing processes, making recommendations for improvements when necessary.
  • Enforces regulatory compliance.
  • Establish and implement appropriate key performance indicators for the department operations.
  • Monitors the performance of the quality control staff, ensuring that the quality control department meets organizational objectives including Good Documentation practices and adherence to Data Integrity requirements.
  • Experience with performing risk assessments associated with EM sampling plans specific to sample site selection and sampling frequencies.
  • Knowledge of performing EM date trend analysis with statistical tools and methods related to assessing adverse trends and identifying key areas for continuous improvement.
  • Experience with performing investigations associated with EM excursions and/or microbial data deviations.

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.
  • Manages entry to intermediate level employees of a department or a function with 1 or 2 sections. Ensures budgets, schedules, and performance requirements are met.
  • 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.

 

Preferred Qualifications

  • Pharmaceutical Manufacturing of Parenteral Solutions.
  • Implementation of EM programs with knowledge/experience with AAMI Technical Information Report 52, ISO 14644, PDA Technical Report 13, USP <1116> and other related industry guidance documents.
  • Knowledge of risk management tools associated with EM sampling plans (e.g. sample site selection, sample frequency, Quality Control vs Process Control samples…etc).
  • Experience with effective data management tools and knowledge of 21 CFR part 11 and ALCOA+ data integrity principles. 

Qualifications

Expertise: Qualifications -Education/Experience/Training/Etc

 

Required:

  • Bachelor's degree required, Master's degree preferred.
  • 08-10 years related experience required.
  • Applicable industry/professional certification preferred.
  • Regular and predictable attendance
  • Occasional business travel 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.

 

 

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.

 

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:

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
  • Frequently:Stand, Sit
  • Constantly:Visual Acuity with or without corrective lenses

Activities:

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

Environmental Conditions:

  • Occasionally:Exposure to toxic or caustic chemicals (in most areas)
  • 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
  • Frequently:Office environment, Production/manufacturing environment, Lab environment
  • Constantly:N/A

 

Notices

Equal Opportunity Employer Veterans/Disabled

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