Sr. QA Specialist - Sterilization

Company: B Braun US Pharmaceutical Manufacturing LLC
Location: Irvine
Posted on: April 12, 2025

Job Description:

B. Braun Medical, Inc.


Company: B. Braun US Pharmaceutical Manufacturing LLC
Job Posting Location: Irvine, California, United States
Functional Area: Quality
Working Model: Onsite
Days of Work: Friday, Thursday, Wednesday, Tuesday, Monday
Shift: 5X8
Relocation Available: No
Requisition ID: 3935

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: Responsible for providing technical expertise and guidance for all activities associated with QC Microbiology and QC Sterilization to support manufacturing and laboratory operational efficiency and compliance while performing routine and non-routine tasks. Responsibilities: Essential Duties

• Provides Quality support to sterilization activities through education, partnering and monitoring for quality compliance while assuring that products and process continue to operate in accordance with company policies and procedures.
• Responsible for managing activities related to validating and revalidating sterilization equipment, methods and products in accordance with industry standards and regulations and company policies and procedures. This includes the development of master plans, maintaining project schedules and development, review and approval of validation protocols and reports to support pre-humidification, sterilization and aeration cycles.
• Operates in accordance with company policies and procedures, FDA Regulations, ISO Standards and Canadian Medical Device Regulations, where applicable.
• Responsible for overseeing Facilities, utilities and Maintenances for maintaining high quality levels., coordinating and administering the company quality program, and ensuring compliance with ISO, internal policies, SOPs, and any relevant external regulations.
• Operates in accordance with company policies and procedures, FDA Regulations, ISO Standards and Canadian Medical Device Regulations, where applicable. The job function listed is not exhaustive and shall also include any responsibilities as assigned by the Supervisor from time to time. Expertise: Knowledge & Skills
  • Requires breadth of professional field and industry knowledge. Ability to integrate critical information and champion advanced strategies/concepts through the organization. Drives development of advanced technologies, principles and processes.
  • Work under minimal supervision. Relies on experience and judgement to plan and accomplish assigned goals. May periodically assist in orienting, training , assigning and checking the work of lower level employees. Referring only complex problems and issues.
  • Judgement is required in resolving complex problems based on experience.
  • Contacts are primarily with department supervisors, leads, subordinates, and peers. Frequent contact with external contractors/vendors. #LI#AL $111,288 - $139,105 Expertise: Qualifications - Experience/Training/Education/EtcRequired:
    • Bachelor's degree required, Master's degree preferred.
    • 08-10 years related experience required.
    • Occasional business travel required.
    • Regular and predictable attendanceDesired: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: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.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, Stand
        • Frequently: Sit
        • Constantly: N/AActivities:
          • Occasionally: Push/pull, Reaching upward and downward, Standing, Talking - ordinary, loud/quick, Walking
          • Frequently: Sitting
          • Constantly: N/AEnvironmental 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: Low
              • Occasionally: Production/manufacturing environment
              • Frequently: Lab environment
              • Constantly: Office environment Equal Opportunity Employer Veterans/Disabled
                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.
                
                All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status.
                
                Compensation details: 111288-139105 Yearly Salary
                
                
                
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Keywords: B Braun US Pharmaceutical Manufacturing LLC, Irvine , Sr. QA Specialist - Sterilization, Other , Irvine, California