Molecular Diagnostic Specialist / Tech writer

Location: Des plains , IL
Pay Range: $22/hr on W2

We are seeking a motivated and detail-oriented individual with a bachelor's degree in biology, preferably with a focus in a specialized discipline such as cell biology, microbiology, or molecular biology. The ideal candidate will have 2-4 years of experience in the relevant field and demonstrate proficiency with Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), and strong documentation skills. This role involves conducting statistical analyses, performing molecular diagnostic assays, and managing change control processes for medical devices, particularly in alignment with new European Union regulations.
Core Responsibilities:

• Perform statistical analysis and hands-on execution of molecular diagnostic assays.
• Gain a comprehensive understanding of assay principles and instrumentation.
• Manage change control packages, particularly for device master records.
• Gather and evaluate attributes of medical devices (100+) in preparation for new European Union regulatory requirements.
• Review product labeling, design records, and device master records to ensure compliance with established timelines.
• Coordinate document control processes, including manufacturing procedures, quality control procedures, certificates of analysis, material specifications, and label and package inserts.
• Ensure well-drafted change impact assessment documents are created and properly redlined.
• Conduct thorough reviews of document changes before submitting them for approval to ensure completeness.
• Ensure that all documentation is appropriately justified, routed, and approved according to established timelines and compliance standards.

Qualifications: 

• Bachelor’s Degree in Biology or Life Sciences, with a preferred focus in Cell Biology, Microbiology, or Molecular Biology.
• 2-4 years of experience in the relevant discipline.
• Familiarity with GMP, GLP, and medical device documentation requirements.
• Strong analytical and problem-solving skills.
• Excellent written and verbal communication skills with attention to detail.
• Experience in managing change control processes and document control is a plus.

Preferred Skills:

• Proficiency with molecular diagnostic techniques and statistical analysis.
• Experience working in regulated environments (e.g., EU medical device regulations).
• Ability to meet deadlines, prioritize tasks, and work in a team setting.

If this is a role that interests you and you’d like to learn more, click apply now and a recruiter will be in touch with you to discuss this great opportunity. We look forward to speaking with you!