Quality Engineer II
Los Angeles, CA
Req ID 51420BR
Business Title
Quality Engineer II
Business
Global Quality
Sub-Business
BioScience Support
Country
US
State/Province
California
Location of Position
Los Angeles, CA
Shift_
1st
Job Description
Operates within the Fractionation Business Unit supporting all operations within the Fractionation Manufacturing Facility. This includes assuring compliance with federal regulations and company procedures, leading and supporting product impact and root cause investigations, implementing corrective and preventive actions, and driving process improvement.
• Support quality initiatives and manages projects within the business unit.
• Assist in the implementation of quality systems procedures and the monitoring of compliance to established procedures.
• Lead small-scale projects or defined portions of large-scale projects. This includes constructing detailed project schedules and interfacing with manufacturing, development, and technical support groups.
• Write, review, approve, and close exception and commitment reports.
• Review investigation reports and verify that the investigation is accurate and complete.
• Perform audits and assessments of manufacturing, manufacturing support areas, and quality systems.
• Identify, investigate, correct and monitor compliance gaps, recurring exceptions, and quality system concerns.
• Assist in customer complaint/adverse events investigations.
• Develop, revise, and review standard operation procedures
• Drive improvements in manufacturing and quality system processes utilizing engineering tools to solve straightforward problems (e.g., FMEA, Process Modeling, Design of Experiments, SPC).
• Establish key performance indicators and monitor/communicate process performance.
• Provide quality/engineering guidance to members of other departments.
Assist in training staff and managing training activities.
Job Requirements
Bachelor's degree in the science/engineering and 3-5 years experience or MS science/engineering and 0-2 years experience in quality assurance, quality engineering, manufacturing engineering or a validation function in a GMP environment.
• Strong knowledge of GMP's with ability to interpret and apply.
• Ability to solve complex problems and provide solutions.
• Ability to operate in a dynamic environment and prioritize multiple tasks.
• Technical understanding of engineering principles and ability to apply.
• Experience with Delta V or similar operations digital automation systems.
• Familiarity with TrackWise.
• Knowledgeable on biotech manufacturing theories and processes.
• Ability to influence peers and management using both written and verbal communication.
• Ability to operate in and facilitate cross-functional teams.
• Proficient in continuous improvement practices (e.g., Lean, Six Sigma, SPC, etc.).
• Ability to effectively run projects, coordinate contractors, and direct the activities of technicians
• Must be able to lift, push, pull and carry up to 25 lbs.
The position requires a combination of desk/computer work and walking around observing conditions in the manufacturing facility.
• Must be able to work in controlled environments requiring special gowning. Will be required to follow gowning requirements and wear protective clothing over the head, face, hands, feet and body.
• Will work in a cold, wet environment
• Must be able to work multiple shifts, including weekends.
Must be able to work overtime as required.
Doing Work that Matters
Baxter provides its employees with comprehensive compensation and benefits. To view additional opportunities at Baxter and to learn more about the company, please visit our Web site at company website. EOE M/F/D/V.
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