Blue Stream Laboratories, a fast-growing biochemical/analytical CRO, seeks a creative, highly-motivated individual who is ready for an exciting, entrepreneurial workplace, and who wants to contribute to a dynamic, success-driven team.

Responsibilities

• Primary responsibility is to perform data review. Experience with HPLC and SDS PAGE is a must.
• Identify and document deviations from controlled procedures. Ensure corrective actions are completed adequately per GMP compliance requirements.
• Assist in QA improvement projects, as required.
• Support data trending, and metrics tracking
• Monitor and support of all laboratory compliance requirements
• Responsible for writing/revising Quality Assurance procedures to strengthen GMP compliance.

Requirements

• Bachelor's degree or equivalent in a life science with 5-7 years experience in QA.
• Experience with GMP document review including specifications, BLA (NDA)/IND documents, method protocols, qualification, validation and analysis reports.
• Basic understanding of quality management systems as well as pre-inspection readiness for regulatory audits which conform to FDA, ICH, and other agencies.
• Adapts diligently to new work requests with general instruction and guidance. Self-motivated.
• Attention to detail in ?troubleshooting?, as well as the ability to interpret and execute test plans, data and documentation review, and final disposition with minimal supervision.
• Excellent interpersonal skills and the ability to communicate well orally and in writing

To apply for this position, please email your resume to dzullo@bluestreamlabs.com. Please specify Job Code WSQAS0722.