Elkem Silicones USA Corp.
Analytical Chemist, Quality Assurance
Under the general direction of their manager, the incumbent in this role will have responsibility to work independently to conduct analytical testing for Quality Assurance release criteria for medical and cGMP regulated products. They will also be responsible for data management and recordkeeping of this information. Their work determines if product meets regulatory requirements and is to be released to our customers.
The work completed by this position is focused on medical and cGMP regulated products which have specific requirements related to regulatory and ISO standards. It involves using highly technical and analytical techniques and is critical for the release of product to customers. A high degree of accuracy, reliability and repeatability is required before product can be released to customers and to be in compliance with regulatory standards for biomedical customers.
Based on their analytical expertise, the incumbent in this role provides advice and guidance to manufacturing, quality, regulatory compliance and supply chain as needed regarding product compliance. He/she is looked to to provide guidance on product testing failures, what is required to meet regulatory requirements, to provide regulatory audit support and is responsible to make the decision about whether to release a product.
- Bachelor of Science Degree in Chemistry, Polymer or other Physical discipline, or related chemical experience
- Minimum of 3-5 years of experience working in chemical manufacturing environment in analytical chemistry. Experience with silicones is a plus.
- Experience with analytical test methods including: HF digestion, ICP-MS, GC-MS, FT-IR, NIR
- Experience with ISO 13485 and GMP and/or GLP is strongly preferred
- Proficient knowledge of Microsoft Office Software applications
- Experience with Minitab or other statistical analysis software
- Experience with SAP transactions and movements
- Good written, oral and listening communication skills with all levels of the organization
- Good interpersonal skills and ability to use these skills to develop working relationships with internal and external customers
- Ability to multitask and manage projects
- Basic understanding of Regulatory Affairs related to medical devices is desirable.