Quality Engineer II

Pure Science. It is the heart of our organization and the DNA of the people who make a career at Invitrogen. Each day, we put the vast potential of biology into action, devising technologies and providing services critical to life science research as well as drug discovery, development and production.Our labs and offices are infused with entrepreneurial energy and intellectual curiosity that foster questions and answers that produce real-world results in laboratories across the globe. In fact, many of the greatest medical discoveries of the last two decades were made using Invitrogen products, including the discovery of the AIDS virus, advancements in cancer treatment, and the development of tools to assist in stem cell research. If you too have a passion for science and the business of biotech, please consider this opportunity:Position Objective Establishes and maintains appropriate Quality Systems 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 FunctionsDesigns, 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. 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. Participates on new product and process design, development and implementation teams.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. Tracks and initiates investigation of complaint trends. Manages the Corrective and Preventative Action (CAPA) system.Provides guidance for and assists with the process (re)validation activities.Responsible for the implementation and management of the internal Quality Audit procedure and schedule.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. Represents the site quality systems to customers in face-to-face meetings or through written and verbal correspondence.May be required to perform other related duties as required and/or assigned.Nature and Scope Works on complex problems in which analysis of situations or data requires an in-depth evaluation of various factors. Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results. Requires working knowledge of cGMP’s and regulations applicable to the FDA. May determine methods and procedures on new assignments. May provide guidance to other lower-level personnel.Education:Requires a Bachelors/Masters degree in chemistry, biochemistry, microbiology, engineering or related discipline.Experience:A minimum of 3 to 5 years related experience and demonstrated working knowledge of compliance, quality and scientific principles. Areas of expertise may include any or all of the following areas; design, manufacturing, research and development, incoming materials, product evaluation and reliability. Experience with word processing, spread sheet and database programs essential. 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 occassional travel.We are proud to be an Affirmative Action / Equal Opportunity Employer committed to hiring a diverse and inclusive workforce.