Amyris is seeking a highly-motivated and collaborative Quality Assurance Engineer III to develop and implement quality systems across global sites in both research and manufacturing. The Quality Assurance Engineer III will be responsible for: (1) ensuring intermediate and final products are within specifications, (2) implementing and upkeep of appropriate quality tracking records, (3) leading the investigation of and correcting non-conformances, (4) maintain the stability program for new and existing products, and (5) supporting new product development teams by implementing Quality Management Systems (QMS). The QMS's will span across functions including suppliers, analytics, manufacturing, CMO's, development and product. The successful candidate will have excellent cross-functional communication skills in interfacing with multiple groups. In addition, experience interfacing with external collaborators to support manufacturing and scale-up activities is required.
Develop and implement quality systems across customer groups, manufacturing and research sites
Ensure alignment of product testing with customer requirements to ensure delivery of product that meets specifications
Ability to analyze data and make recommendations
Ensure proper QMS's for control of materials, manufacturing and packaging operations, sanitation, test and inspection, and final disposition of the product.
Work with Quality Control, Logistics, R&D and Product Management to ensure that all documentation, specifications and methodology are in place to support manufacturing and ensure complete customer satisfaction.
Identify, investigate, and coordinate responses to internal and external non-conformances
Maintain appropriate quality tracking records (certificates of analyses, control charts, calibration records etc.)
Participate in the review of existing and proposed specifications, standard operating procedures, and manufacturing batch records
Provide specification development, manufacturing capability review and approval of all new customer specs.
Develop stability protocols to ensure new and existing products meet stability requirements.
Support disposition of product as necessary to support business development
Provide final release authority on all customer products and samples
4+ years of Quality Assurance experience in chemical / continuous flow manufacturing
BS in Chemistry or Engineering degree
Energetic, highly self-motivated and able to work efficiently and productively in a rapidly growing company
Strong ability to evaluate processes and to facilitate effective change
Excellent cross-functional collaboration, communication, and interpersonal skills
Strong project management skills
Ability to work independently to support quality goals
Proficiency in writing and oral presentations
Ability to travel as needed approximately 25% of time
ISO9000 corporate qualification and compliance experience is a plus
Amyris, a leader in industrial synthetic biology, uses its innovative bioscience solutions to achieve renewable products by converting plant sugars into hydrocarbon molecules. Amyris' molecules are used in wide range of specialty & performance chemicals, flavors & fragrances and in applications ranging from cosmetics to biofuels. Learn more at www.amyris.com.
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