Quality Investigator; Mon - Fri

Overview

Quality Investigator (Mon - Fri 8 AM - 5 PM). Company:

B. Braun US Pharmaceutical Manufacturing LLC.

Location:

Irvine, California, United States.

B. Braun Medical Inc. develops, manufactures, and markets innovative medical products and services to the healthcare industry. 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.

Provide support to functional groups on proper investigations, maintaining standard work through trend analysis, lean manufacturing principles, engineering studies, process and test method development and validation, and statistical process control. Conduct investigations including DSMS, Product Complaints, Internal and External audits, Process verifications performed by QC Process Control, and Reserved sample discrepancies. Interface with Quality Assurance, Engineering, Manufacturing, Regulatory Affairs and other technical functions.

Conduct impact assessments for process deviations and discrepancies, including Out of Tolerance (OOTI) calibration reports. Investigate manufacturing nonconformities and recommend, develop and implement corrective actions. Ensure investigations are thorough, accurate, and conducted in a timely manner. Maintain discrepancy files per company policies and procedures. Ensure controls are in place to effectively and accurately process discrepancies. Serve as a Quality representative to improve awareness, visibility and communication on quality initiatives to support quality goals.

Serve as primary contact for investigation support of the QO/QA department. Create, follow up and drive QCRV to completion; review and maintain closed QCRV documents to meet compliance standards.

• Perform quality investigations for non-conformances by reviewing data, master history records, and interviewing personnel.
• Obtain information from SMEs, publications, manuals and other sources.
• Complete the investigation write-up.
• Present investigation results to Quality Management.
• Write and conduct quality protocols as required.
• Review quality records and conduct timely quality reviews of data and documents to support batch release.
• Assist in complying with regulatory requirements related to product safety and quality.
• Oversee quality operations systems (e.g., QCRV, IR, Process Verification).

The job function listed is not exhaustive and may include additional responsibilities as assigned by the Supervisor/Manager. General:
It is the duty of every employee to take reasonable care for safety and health of themselves and others.

• Requires basic knowledge of relevant business practices and procedures; uses standard theories and concepts to propose actions.
• Works under general supervision; relies on experience and judgment to plan and accomplish goals; may assist in orienting/training others.
• Judgment is required in resolving day-to-day problems; contacts are primarily with supervisor, peers and subordinates.

Required:

• Bachelor’s degree or equivalent combination of education and experience.
• 2-4 years related experience.
• Applicable industry/professional certification preferred.
• Regular and predictable attendance.

Physical requirements:

The employee is regularly required to sit and talk or hear; use hands; occasionally stand, walk, and lift up to 20 pounds.

• Work environment includes office and production/manufacturing settings with moderate noise.
• Reasonable accommodations may be made for individuals with disabilities to perform essential functions.

$79,000.00 - $89,000.00 annually. The range reflects factors such as skills, experience, licensure, and organizational needs. Geographic differential considerations may apply.

B. Braun offers an excellent benefits package (healthcare, 401(k), tuition reimbursement). For more information and other employment opportunities, visit  Through its Sharing Expertise initiative,

B. Braun promotes best practices for continuous improvement of healthcare products and services.

Equal Opportunity:
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.