SeraCare Life Sciences partners with diagnostics researchers, IVD manufacturers and clinical laboratories to shape the future of medical diagnostics. Our innovative portfolio includes ACCURUN® quality controls, research panels; SeraCon® processed biological materials, specialty human blood products and characterized disease state materials. SeraCare helps bridge the gap between today’s diagnostic solutions and tomorrow’s emerging technologies for molecular diagnostics, next generation sequencing and companion diagnostics.
The individual in this role will provide Quality Engineering expertise, support, and training as required for Quality and Operational departments to ensure consistency and compliance. This person will lead Supplier Quality function to ensure suppliers meet SeraCare raw material specifications and quality/regulatory requirements. The individual will work closely with other departments/groups within the company to apply statistical methods and perform product/process/risk analysis for cost reduction, quality improvement, and enhanced efficiency. This person will provide direct support and/or QA oversight and review of commissioning and validation activities and documentation. The Quality Engineer will also conduct internal audits and supplier audits. This individual will need to establish robust quality systems and processes that produce repeatable results. This person will drive organizational improvements through metric establishment, tracking, and action plans.
A Bachelor’s degree & five to ten years’ experience in a pharmaceutical/biotech environment is required including significant experience in the application of cGMP/ ISO 13485/ISO 9001 requirements. Demonstrated experience performing quality audits of vendors and contractors while professionally representing the company is also required. This individual must be able to demonstrated experience as a QE in an IVD/Medical Device environment. This person must have experience in the application of statistics and statistical process controls, process validation, equipment validation and the review and approval of documents associated with the design, build, commissioning, and validation of cGMP and ISO compliant processes, equipment and facilities. A sense of urgency and the ability to focus on accomplishing day-to-day responsibilities is required. This individual must be extremely reliable, trustworthy and self-motivated to work independently and as part of a team. This person must show they have the ability to be flexible to changing priorities-while maintaining high productivity levels. Possessing excellent problem-solving, written and verbal communication, interpersonal, and team-building skills is required as well as the ability to communicate cross functionally internally/externally and with all levels of the organization. The person in this role must also have the ability and willingness to travel up to 20%. A strong proficiency in MS Word, Excel, Visio, and PowerPoint is required. A working knowledge of SAP would be a plus. Must be able to read, write, speak fluently and comprehend the English language.
SeraCare Life Sciences, Inc. is an Equal Opportunity Employer, M/F/D/V
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