Technical Writer/QC Analyst

Job Title: Technical Writer/QC Analyst

Location: Rockville, MD 20850 (Onsite)
Duration: 6 Months (Temp-to-Hire)
Pay Rate: $30.00/hour (W2)

Job Summary

We are seeking a Technical Writer with hands-on QC laboratory experience in a biologics, biotechnology, pharmaceutical, or GMP-regulated environment. The ideal candidate will have strong experience in technical writing, GMP documentation, SOP authoring, investigations, and quality documentation, along with supporting QC operations.

This role partners with Manufacturing, Quality, and MSAT teams to develop and maintain GMP-compliant documentation while supporting compliant, efficient, and inspection-ready manufacturing operations.

Key Responsibilities

• Author, revise, and maintain SOPs, protocols, reports, specifications, and controlled GMP documentation.
• Review batch records and support deviation investigations.
• Support CAPA activities, root cause investigations, and documentation updates.
• Develop technical and training documentation for manufacturing and quality operations.
• Support process improvement, technology transfer, process validation, and manufacturing optimization initiatives.
• Collaborate with Manufacturing, Quality, Engineering, and MSAT teams to improve operational efficiency.
• Ensure documentation complies with cGMP, GDP, FDA, and regulatory requirements.
• Interpret scientific and technical data and translate it into clear, accurate technical documentation.
• Maintain documentation within document management systems and support inspection readiness.

Required Qualifications

• Bachelor's degree in Science, Engineering, or a related discipline.
• Minimum 3 years of industry experience.
• Hands-on QC laboratory experience, preferably as a QC Analyst in a biologics, biotechnology, pharmaceutical, or other GMP-regulated environment.
• Strong technical writing experience in a regulated GMP environment.
• Experience with:
  • Analytical testing
  • Reviewing laboratory test results
  • Investigations
  • SOPs
  • Specifications
  • Protocols
  • Technical reports
  • Controlled quality documentation
• Strong understanding of cGMP, GDP, and FDA regulations.
• Excellent organizational, communication, and Microsoft Office skills.

Preferred Qualifications

• Experience in biologics, cell therapy, or gene therapy.
• Knowledge of Lean Manufacturing and continuous improvement methodologies.
• Experience supporting process validation, technology transfer, or manufacturing operations.
• Experience with document management systems.