QA Microbiology/Sterilization Specialist / 1541 Job in Irvine 92614, California US
Position Description: Since its founding in 1839, B.
Braun has built an unparalleled store of knowledge and expertise in delivering innovative healthcare products, medical devices and programs that enhance working processes in hospitals, alternate care settings and medical practices increasing safety for patients, doctors and nurses.
Its 38,000 employees worldwide are proud of their commitment to translating customer needs into products with unmatched quality, superior technology, cost-effectiveness and environmental responsibility.
We are currently seeking a QA Microbiology/Sterilization Specialist.To qualify for this position, candidates must possess/or meet the following requirements: Education: * BS degree in microbiology; MS / Ph.D preferred.
* Five (5) years of experience in quality assurance in the pharmaceutical or medical device industry.
* Knowledge in CFR, USP, cGMP, AAMI, and other FDA regulations.
* Knowledge in Thermal Kinetics.
* Knowledge in Aseptic Processing.
ESSENTIAL FUNCTIONS: * Manage implementation and control of microbiology and sterilization quality assurance programs for B.
Braun to ensure product reliability, quality, efficacy, compliance to applicable state and federal regulations, cGMPs, and internal standards for manufacturing, materials, and finished products.
Provide technical review, direction, and approval in the area of microbiology and sterilization for CAPAs, non-conformances, customer complaints, internal audits, deviations, technical data, SOPs, and new product developments to ensure adherence to quality objectives and standards.
Essential Functions: * Manage Quality Assurance Program and project deliverables for R & D projects.
* Establish qualifications and validate standards for new products and processes.
* Review, disposition, and provide technical direction for product quality (NLR), CAPA, PPDR, Deviations, Internal Audit, CALNs, OOS, and product complaint investigations and corrective and preventive actions related to microbiology and sterilization.
* Reviewing standard operating procedures (SOPs), technical data, and reports.
* Assist manager in R & D budget preparation / allocation.
* Support FDA, external, and internal auditsBBraun offers an excellent benefits package, which includes healthcare, a 401(k) plan, company sponsored pension, 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 An EOEThrough its Sharing ExpertiseŽ initiative, B.
Braun promotes best practices for continuous improvement of healthcare products and services.
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