Responsibilities:

The Quality Assurance Specialist is responsible for independently performing multiple activities in support of Quality initiatives.

• Initiate and assist in conducting investigations, resolving deviations, OOS/OOT and review corrective action plans for adequacy per GMP compliance requirements
• Provide support for document life cycle maintenance including, but not limited to
  • Document preparation, including formatting of all GMP documents
  • Responsible for maintenance of all QA log books
• Assist in QA improvement projects, as required
• Assist with hosting internal audits, as well as conducting internal and external audits
• Support review and disposition of controlled documents and associated raw data and subsequent archiving
• Support data trending and providing metrics with minimal supervision
• Assist with maintenance and organization of internal record-keeping to ensure compliance
• Consistently enforce employee compliance
• Assist in providing QA support to laboratory staff

Qualifications:

• Bachelors degree or equivalent in a life science with 5-7 years experience.
• Experience with GMP document review, including certificate of analysis, specifications, BLA (NDA)/IND documents, methods, protocols, qualification, validation and analysis reports.
• Basic understanding of Quality Management Systems as well as pre-inspection readiness for regulatory audits which conforms to FDA, ICH, and other health agencies.
• Experience managing projects and programs
• 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 WSQAS0330.