A leading biotech company are searching San Diego for a Quality Specialist 2 on a 6 month contract basis! They are looking for someone with Document Control Experience as well as, Quality assurance experience in all aspects of device/diagnostic quality systems. The ideal candidate will be familiar GDP, FDA Quality systems regulations and ISO standards
Hourly pay Range: $30-36 per hour
Some Key Responsibilities:
- Manage the document control program (change request/change orders) as well as suggest and implement improvements to existing process
- Monitor change activities such as review/approval/implementation and be able to resolve issues of varying complexity
- Interface with internal and external customers to convey requirements and resolve issues to drive efficient and effective process
- Write, edit, review and maintain procedural documentation including, but not limited to, department policies, procedures and guidance documentation
- Perform trending analysis (Quality Metrics) on an as needed basis, including using statistical process control methods
- May assist in the investigation and resolution of nonconforming events and CAPA projects
Some Key Requirements:
- 2-4 years of direct work experience in QA, including all aspects of device/diagnostic quality systems
- Managing document control systems (electronic preferred) is required
- Experience working in an ISO 13485 or CAP/CLIA regulated environment
- Excellent problem solving and analytical skills Effective interpersonal and communication skills and capable of supporting cross-functional project goals
- An understanding of GDP, FDA Quality System Regulations, CLIA and/or ISO Standards (ISO 13485 and ISO 14971) is a plus, Quality engineering experience is a plus
Educational Requirements:
- HS Diploma/GED
If you feel like you are the right person for the job, please apply with a recent resume to be considered!
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