Quality Assurance Specialist

1 week ago

St Louis, Missouri, United States EMD Full time
Quality Scientist (QC Microbiology) Job Description

At EMD, we are committed to creating access and opportunities for all to develop and grow at your own pace. We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology.

Job Summary:

The Quality Scientist (QC Microbiology) is responsible for microbiology-related analysis, including in-process, drug substance, raw material, and water sample endotoxin analysis. This role involves method validation, development, and associated endotoxin verification of in-process and drug substance samples.

Key Responsibilities:
  • Ensure that suitable written records and work undertaken are kept in accordance with cGMP and company procedures.
  • Work within various internal departments to improve and execute processes used in an ICH Q7 environment.
  • Assist with OOS/OOT investigations and root cause analysis investigations.
  • Interact with production and laboratory personnel regularly to ensure adequate communication and feedback for quality-related services to internal customers.
  • Maintain and update relevant Ops.
Requirements:
  • Bachelor's Degree in Biology, Chemistry, or other life science discipline.
  • 5+ years of QC lab experience in endotoxin and bioburden analysis (chromogenic, turbidimetric, and gel-clot methods).
  • Preferred Qualifications:
    • Current API knowledge and/or experience.
    • Knowledge of SOPs, cGMPs, GLP, GDP, and quality control processes.
    • Knowledge and understanding of endotoxin testing, LER/hold time studies; verification testing.
    • Experience with ICH Q7, 21CFR210, USP, USP, and EP pharmacopeia requirements.
    • Experience writing technical documents and reports.
    • Strong knowledge of aseptic technique and practices.
    • Ability to perform minor troubleshooting on microbiological processes and associated laboratory equipment.
    • Experience with documentation control: writes, reviews, and approves operating procedures, reports, protocols, and other QC controlled documents.
    • Experience independently writing verification protocols and final reports.
    • Familiar with basic scientific/regulatory principles.
    • Excellent written and verbal communication skills.
    • Capacity to work independently.
    • Fosters collaboration and teamwork.
    • Ability to simultaneously manage multiple tasks/priorities; good computer skills, including proficiency in MS Word, MS Excel, MS PowerPoint, and the ability to learn and operate other specific application software.
    • Good problem-solving and time management skills.

We are passionate about caring for our rich mix of people, customers, patients, and planet. If you would like to know more about what diversity, equity, and inclusion means to us, please visit this link.

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