GMP QC Investigation Lead & Technical Writer

Indotronix Avani Group; High Point (NC); On-site; USD 28,000 - 50,000; Full time

Job summary

Indotronix Avani Group is seeking a Quality Control Investigation Writer in High Point, NC to lead and author GMP-regulated laboratory investigations. The role requires extensive experience with OOS, OOT, EM, deviations, and data integrity within a pharmaceutical setting.

You will collaborate with QC analysts, QA, Microbiology, Manufacturing, and other teams to determine root causes and develop CAPAs, ensuring regulatory compliance and timely completion of investigations.

Qualifications

• Bachelor's degree in Chemistry, Microbiology, Biology, Biochemistry, Pharmaceutical Sciences, or related field required.
• Minimum 2 years in GMP-regulated pharmaceutical/biotech environment.

Responsibilities

• Lead and author QC laboratory investigations (OOS, OOT, EM, deviations).
• Collect, review, and analyze laboratory data and supporting documentation.
• Facilitate investigation meetings with cross-functional teams to determine root causes.

Skills

Quality investigations

Technical writing

Data review

Cross-functional collaboration

Education

Bachelor's degree in sciences

Tools

TrackWise

Job description

Indotronix Avani Group is seeking a Quality Control Investigation Writer in High Point, NC to lead and author GMP-regulated laboratory investigations. The role requires extensive experience with OOS, OOT, EM, deviations, and data integrity within a pharmaceutical setting.

You will collaborate with QC analysts, QA, Microbiology, Manufacturing, and other teams to determine root causes and develop CAPAs, ensuring regulatory compliance and timely completion of investigations.