Job Title : Quality Assurance Specialist
Summary : Are you someone who is passionate about having a hand in changing the lives of patients across the globe? My client is one of the largest vaccine businesses in the world, with over 40 vaccines in their portfolio. With vaccines ranging from malaria, Shingles to RSV, there are no limitations as to what this company can offer. Leading in HIV and respiratory treatments, my client is seeking someone who is looking to make a change. If you are someone who is a self starter, looking to take on multiple challenges and has excellent communication skills, this may be the position for you!
The Quality Assurance Specialist will be responsible for :
- Supporting Operations through real-time, online documentation QA review and approval.
- Technical review of cGMP documentation for completeness and compliance.
- Support QA on the floor and performing QA Operation activities (validation lifecycle, documentation, area release, etc.)
- Deviation investigations, customer complaint investigations and other discrepancies and/or anomalies during QA review of associated processes.
- Write and/or revise controlled documents.
- Ensuring all GMPs, validation, quality, safety and environmental regulations are met.
The Quality Assurance Specialist should have the following requirements :
- Bachelor's Degree in Biology, Chemical Engineering or Life Sciences related field.
- At least 3 years of experience in Quality Assurance or manufacturing technician, preferably in Biologics
- Have a technical understanding of industry and science practices related to daily activities.
- Knowledge of GMP, NIH and FDA guidelines to apply to quality operations and compliance.
- Experience with root cause analysis tools (Isikawa) is required.
If this sounds like something you would be interested in, please apply!
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