Company Description

QRC Group, LLC is a firm dedicated to offer services to the Pharmaceutical, Medical Devices and Chemical Industries in the validation and regulatory fields.

Log on now to our website http://wwwqrcgroup.com/ to learn more about our services and solutions!

Job Description

The Technical Writer is responsible for review, editing, and maintaining high-quality documentation that supports pharmaceutical product development, manufacturing, and regulatory compliance. This includes protocols, standard operating procedures (SOPs), and regulatory submissions. The role requires close collaboration with scientists, regulatory specialists, and quality teams to ensure all documentation is scientifically accurate and aligned with industry regulations and internal standards.

• Revise and editing technical documents and regulatory filings.
• Ensure all documentation complies with FDA, and the internal quality systems.
• Collaborate with subject matter experts (SMEs) to gather and verify technical content.
• Support audits and inspections by maintaining organized and accessible documentation.
• Collaborate effectively with cross-functional teams.

Qualifications

• Bachelor’s degree in Life Sciences, Engineering, Pharmacy, Technical Communication, or a related field.
• Minimum of 2–3 years of experience in technical writing within the pharmaceutical, biotechnology, or medical device industry.
• Proven experience with GMP documentation, validation protocols, and regulatory submissions (e.g., FDA, EMA, ICH).
• Proficiency in document management systems.
• Knowledge of Good Documentation Practices (GDP) and quality system standards.
• Bilingual (English/Spanish)

Additional Information

All your information will be kept confidential according to EEO guidelines.