Sr. QA Specialist - Sterilization

B. Braun; Irvine (CA); On-site; USD 115,000 - 140,000; Full time

Job summary

B. Braun US Pharmaceutical Manufacturing LLC in Irvine, CA, is seeking a Senior QA Specialist – Sterilization to provide quality and technical expertise in sterilization and microbiology activities supporting manufacturing and laboratory operations.

The role leads validation and revalidation of sterilization equipment and processes, develops strategies, reviews protocols, and ensures compliance with FDA regulations, ISO standards, and quality systems while collaborating with Quality,

Qualifications

• Bachelor’s degree in microbiology, biology, engineering, life sciences or a related technical discipline.
• Minimum 8 years of related experience in QA, sterilization, microbiology or validation in a regulated manufacturing environment.
• Experience with sterilization process validation/revalidation and validation protocols, reports and plans.
• Working knowledge of FDA regulations, ISO standards and quality system requirements.
• Strong technical writing, problem-solving, communication and cross-functional collaboration.
• Ability to travel occasionally and maintain regular attendance.

Responsibilities

• Provide Quality oversight and technical guidance for sterilization activities to maintain product and process compliance.
• Lead validation and revalidation of sterilization equipment, methods and products.
• Develop validation strategies and master plans, manage schedules, and author, review and approve protocols and reports.
• Resolve complex sterilization and microbiology issues using sound scientific and quality judgment.
• Ensure compliance with company procedures, FDA regulations, applicable ISO standards and Canadian Medical Device Regulations, where applicable.
• Partner with internal teams and external contractors/vendors, and provide technical guidance or training to less-experienced employees.

Skills

Quality oversight

Sterilization expertise

Cross-functional collaboration

Technical writing

Problem-solving

Travel readiness

Education

Bachelor’s degree in microbiology/related

Master’s degree preferred

Job description

You’re an important part of our future. Hopefully, we're also a part of your future! At B. Braun, we protect and improve the health of people worldwide. You support this vision, bringing expertise and sharing innovation, efficiency and sustainability as values. That’s why we would like to keep developing our company with you. Keeping your future in mind, we’re making a joint contribution to health care worldwide, with trust, transparency and appreciation. That's Sharing Expertise.

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: 14752

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

The Senior QA Specialist – Sterilization provides quality and technical expertise for sterilization and related microbiology activities supporting manufacturing and laboratory operations. This role helps keep processes, equipment and products validated, compliant and inspection-ready while partnering across Quality, Manufacturing, Engineering, Laboratory teams and external vendors.

In this role, you will have the chance to:

• Provide Quality oversight and technical guidance for sterilization activities to maintain product and process compliance.
• Lead validation and revalidation of sterilization equipment, methods and products, including pre-humidification, sterilization and aeration cycles.
• Develop validation strategies and master plans, manage schedules, and author, review and approve protocols and reports.
• Resolve complex sterilization and microbiology issues using sound scientific and quality judgment.
• Ensure compliance with company procedures, FDA regulations, applicable ISO standards and Canadian Medical Device Regulations, where applicable.
• Partner with internal teams and external contractors/vendors, and provide technical guidance or training to less-experienced employees.
• Bachelor’s degree in microbiology, biology, engineering, life sciences or a related technical discipline.
• Minimum 8 years of related experience in Quality Assurance, sterilization,microbiology or validation within a regulated manufacturing environment.
• Experience with sterilization process validation/revalidation and validation protocols, reports and plans.
• Working knowledge of FDA regulations, applicable ISO standards and quality system requirements.
• Strong technical writing, problem-solving, communication and cross-functional collaboration skills.
• Ability to work independently, support external contractors/vendors and travel occasionally; regular and predictable attendance is required.

Preferred Experience Includes

• Master’s degree in a scientific, engineering or related technical discipline.
• Experience with sterilization cycles and QC Microbiology controls for sterile or sterilized products.
• Experience mentoring or providing technical direction to Quality or laboratory personnel.

Physical Demands & Work Environment

The following represents the typical physical demands and work environment of this position. Reasonable accommodations may be made for individuals with disabilities.

Work is primarily performed in office and laboratory settings, with occasional exposure to production/manufacturing areas and generally low noise.

The role requires frequent sitting; occasional standing, walking, reaching, pushing/pulling and talking; and lifting or moving up to 20 lbs. occasionally and 10 lbs. frequently.

Other Duties

The duties listed are representative and not exhaustive. Management may add, modify or reassign responsibilities due to reasonable accommodation or other business needs.

Compensation

$115,000 - $140,000

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 .