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Position Title: Biotech Manufacture Quality Engineer - 4 Positions
Location: Camarillo, CA 93012
Salary: $21.48-24.44/hour
Establishes and maintains appropriate Quality Systems elements consistent with GMP and/or ISO requirements. Assures compliance to in-house and/or external specifications and standards. Actively contributes to the data collection, trend analysis, investigation and improvements to processes, products and systems.
Essential Functions
Designs, evaluates, implements and maintains quality assurance programs and systems for product and/or process development, manufacturing and testing to ensure product quality and compliance with regulatory requirements.
Develops methods and protocols to ensure that appropriate quality assays and/or tests are being conducted.
Develops material specifications for in-coming chemeicals, antibodies and components; in-process material s and finished good products.
Works with quality and manufacturing to create and/or modify methods and procedures to ensure that appropriate processes and/or products are developed, tests are conducted and that products, materials, and manufacturing equipment meet required standards.
Performs statistical analysis to analyze trends, and works with manufacturing to investigate trends, conduct root cause analysis and recommend corrective actions for processes and products.
Assures the development and utilization of equipment calibration and preventative maintenance systems.
Provides guidance for and assists with the process (re)validation activities.
Assures compliance to in-house and/or external specifications to standards, such as GMPs and ISO regulations, and approves disposition for non-conformances on raw materials and finished goods.
May be required to perform other related duties as required and/or assigned.
Nature and Scope
Works on problems of diverse scope in which analysis of data requires evaluation of identifiable factors. Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions. Requires familiarity of cGMP’s and regulations applicable to the FDA and European Directives. Normally receives no instructions on routine work, general instructions on new assignments. Requires strong, persuasive communication skills both verbally and in writing.
Contacts:
Has contact with all internal operations, commercial, IT, Customer Service, and Distribution employees. Will also have frequent interactions with colleagues at other Invitrogen sites involved with Quality Systems. Needs to interact effectively with others throughout the organization in both project leader and/or team member roles.
Working Conditions:
Works in a team based office environment with some laboratory involvement. Close attention to detail required. Is required to lift up to 20 lbs. May be required to sit or stand for long periods of time while performing duties. Must be able to work safely with chemicals and hazardous materials. Must be able to work outside of regular work hours and be available for occasional travel
