Basic Function and Scope of Position
This position supports quality assurance activities related to quality system compliance and continuous improvement. The ideal candidate will have a Quality Assurance background in an in vitro diagnostic or molecular reagent company and/or a product development background in molecular biology products or molecular diagnostic products company utilizing nucleic acid technology (e.g. PCR, sequencing, etc) is a plus.
All About You
- Manage or support the training program as well as suggest and implement improvements to existing process.
- Manage or support the document control program as well as suggest and implement improvements to existing process.
- May assist in the investigation and resolution of nonconforming events and CAPA projects.
- Support the batch record review process this may include the review, investigation and resolution of issues with batch records.
- Perform trending analysis (Quality Metrics) on an as needed basis, including using statistical process control methods.
- Work with management to improve quality system policies and procedures.
- Assist in internal and external audits.
- Write and/or review documents.
- Perform other duties as assigned