Quality Investigator; Mon - Fri

Overview

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.

Quality Investigator (Mon - Fri 8 AM - 5 PM)

B. Braun US Pharmaceutical Manufacturing LLC

Irvine, California, United States

Quality

Onsite

Friday, Thursday, Wednesday, Tuesday, Monday

5X8

No

9275

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

Conduct impact assessments for process deviations and discrepancies, including Out of Tolerance (OOTI) calibration reports. Conduct and support investigations of manufacturing nonconformities and recommend, develop and implement effective corrective actions. Ensure that investigations are thorough, accurate and being conducted in a timely manner. Ensure that Discrepancy files are properly maintained in accordance with company policies and procedures.

Assure that 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 departmental, functional, facility and corporate quality goals and objectives. Serve as primary contact for investigation support of the QO/QA department.

Responsible to create, follow up and drive QCRV to the completion. Review and maintain the closed QCRV documents to ensure it meets the compliance standard requirements.

• Perform Quality investigation for non-conformances by reviewing data, master history records, interview personnel.
• Obtain information from SME's, 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.
• Conduct timely Quality review of associated data and document to support batch release, to meet business and operations requirements.
• Assists in complying with regulatory requirements related to product safety and quality.
• Oversee quality operations system (i.e., QCRV, IR, Process Verification, etc.).

The job function listed is not exhaustive and shall also include any responsibilities as assigned by the Supervisor/Manager from time to time.

• Requires basic 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.
• Works under general supervision. Relies on experience and judgement to plan and accomplish assigned goals. May periodically assist in orienting, training, and/or reviewing the work of other peers.
• Judgement is required in resolving all day-to-day problems.
• Contacts are primarily with direct supervisor, peers and subordinates.

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

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…