Biotech Quality Assurance Specialist
4 days ago
We are seeking a skilled Biotech Quality Assurance Specialist to join our team in Germantown, MD. This role is responsible for providing testing and technical support for our clinical development product pipeline, regulatory findings, and operations related to the Quality Control Microbiology Testing group.
Key responsibilities include:
- Supporting the overall scientific and technical efforts of the Quality Group as it pertains to Microbiology and Raw Material Testing.
- Providing oversight for Microbiology/Raw Material testing associated with OTLs and CMOs.
- Troubleshooting and investigating trends in Microbiology/Raw Material method performance associated with OTLs and CMOs.
- Writing, reviewing, and editing SOPs and reports.
- Supporting the activities of the Microbiology Laboratory including sampling and testing, analysis, and determining if the results meet acceptance criteria.
- Supporting the activities of the Raw Material Laboratory, including receiving and sampling of raw material test samples and retains and determining if results meet acceptance criteria
- Supporting Microbiology and Raw Material outsourcing of test samples including submission and shipping to outside testing labs (OTL's), reviewing OTL results, and completing testing documentation.
- Supporting equipment cleaning and general laboratory maintenance for the Microbiology and Raw Material Laboratories
- Maintaining inventory for consumables used in the QC Microbiology and Raw Material Laboratories
- Supporting quality-related events such as deviations, CAPA, OOS investigations, and change controls
- Reviewing of data generated from Microbiology and Raw Material Testing.
- Supporting trending of EM and utility data
- Working cross-functionally with various internally (E.g.: Manufacturing, Quality Control, Quality Assurance and Validation) and externally (E.g.: CMOs, OTLs, etc.)
- Maintaining accurate written records compliant with current GMP, GLP, and GDP requirements and company procedures.
- Attending general and/or cross-functional meetings as required .
To be successful in this role, you will need:
- Bachelor's degree in biological science. QC Microbiology experience required.
- 2+ years of years' experience in a cGMP laboratory, preferably related to pharmaceutical/biotech operations industry
- Experience in working with GMP documentation including SOPs, deviations and assay protocols.
- Preferable strong technical background in general QC Micro and/or Raw Material Testing.
- Proficient in Windows based software including Excel and Word.
- Experience in sample and data tracking software such as quick base.
- Good communication (oral, written, presentation) and organizational skills.
- Ability to multi-task and work independently.
- Experience with LabVantage or other LIMS platforms a plus but not required.
This position offers an annual salary range of $66,100 - $82,600, depending on experience and qualifications. Novavax also offers a comprehensive benefits package, professional career development opportunities, and a bonus structure that rewards outstanding performance. We are an equal employment opportunity employer committed to fostering a diverse and inclusive workplace culture.
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