Remote QC Documentation & Investigation Specialist

Medivant Healthcare; United States; Remote; USD 90,000 - 130,000; Full time

Job summary

Medivant Healthcare in the United States seeks a QC Documentation Specialist to support cGMP compliance, review analytical data, and lead investigations (OOS/OOT), drafting reports and ensuring timely closeout. You will maintain electronic quality systems, coordinate CAPAs, and train staff, collaborating with QA, Manufacturing and R&D teams in a remote, cross-site environment.

The role requires 5+ years in pharmaceutical QC, strong data integrity understanding, and excellent attention to detail

Qualifications

• 5+ years of experience in pharmaceutical Quality Control with strong emphasis on QC documentation and investigations.
• Solid knowledge of cGMP, FDA requirements, USP, ICH guidelines, GDP, and data integrity.
• Experience with OOS/OOT investigations, deviations, CAPA, laboratory errors, and data review.
• Experience reviewing HPLC/UPLC, GC, UV, FTIR data or related analytical results.
• Proficient communication skills, ability to work remotely with cross-location teams.

Responsibilities

• Support QC team to maintain compliance with cGMP, FDA, USP, ICH, GDP, and internal quality procedures.
• Review and ensure accuracy of QC records, test results, and electronic records.
• Lead or support investigations related to OOS, OOT, deviations, and CAPA.
• Coordinate CAPA and investigation documentation, timelines, and impact assessments.
• Draft and update SOPs, methods, specifications, protocols, and reports.

Skills

Attention to detail

Strong written and verbalcommunication

Independent, remote work capability

Education

Bachelor's or Master's in Pharmaceutical Sciences, Chemistry, Analytical Chemistry, or related

Tools

Electronic quality/document management systems

Job description

Medivant Healthcare in the United States seeks a QC Documentation Specialist to support cGMP compliance, review analytical data, and lead investigations (OOS/OOT), drafting reports and ensuring timely closeout. You will maintain electronic quality systems, coordinate CAPAs, and train staff, collaborating with QA, Manufacturing and R&D teams in a remote, cross-site environment.

The role requires 5+ years in pharmaceutical QC, strong data integrity understanding, and excellent attention to detail