3Key Consulting, Inc. in Simi Valley, CA is seeking a Quality System Engineer with quality and manufacturing experience in the biotech or pharmaceutical industry. Individuals will apply advanced theoretical knowledge of biomedical principles and concepts, as well as experience with pharmaceutical regulations and process validation to perform the following duties:

• Apply analytical skills to evaluate complex situations using multiple sources of information.
• Manage multiple Quality System projects that include managing system corrections, defects and enhancements to ensure compliance with quality system requirements.
• Coach and manage project teams by providing feedback on deliverables scheduling, intent of results, prioritization of tasks and development of project strategy.
• Execution of regulatory and SOP requirements.
• Anticipates and prevents potential issues with regulators.
• Provides guidance and technical advice.
• Evaluates subject matter experts’ assessment.
• Owns complex quality record content.
• Proposes revisions to SOPs in area of responsibility.

Minimum requirements: Master’s degree in Biomedical Engineering, Biotechnology, Computer Science, any STEM (Science, Technology, Engineering, or Math) field, or any related field of study, plus two (2) years of experience in the job offered or in any related position(s) in which the required experience was gained.

Qualified applicants must also have demonstrable proficiency, skill, experience, or knowledge with the following:

• Must have experience with Minitab, TrackWise, Product Catalog Management Tool (PCMT), Excel, Complaints management system (Salesforce platform).
• Manufacturing/testing processes: API, Drug Substance, Drug Product, Packaging, Device manufacturing processes.

Work from home benefit. The employee may need to travel locally to complete the duties of this position.
Ability to travel +/- 10% of time to domestic sites.

Additional Information:
Job Site: 4565 Industrial St., Ste. 7-B, Simi Valley, CA 93063
Salary: $83,782 to $88,000 per year.
Send Resumes To: hr@3keyconsulting.com
No calls. EOE.
Must be legally authorized to work in the United States without sponsorship.

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