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 for a 12-month contract. The role leads and documents GMP-regulated QC investigations, including OOS, OOT, EM, and deviations, coordinating with cross-functional teams to determine root causes and product impact.

We require a Bachelor’s degree in a scientific field and 2+ years in GMP environments, with strong technical writing skills and familiarity with TrackWise.

Qualifications

• Advanced technical writing and documentation skills.
• Strong knowledge of FDA regulations, cGMP and laboratory investigations.
• Experience with data review of laboratory results and documentation.

Responsibilities

• Lead and author QC investigations (OOS/OOT/EM/deviations).
• Coordinate with QA, Microbiology, Manufacturing and other teams.
• Perform root cause analyses and develop CAPAs/Change Controls.
• Prepare investigation reports meeting GMP and FDA expectations.
• Ensure timely review and closure of investigations.

Skills

Advanced technical writing

Data analysis

Regulatory knowledge

Communication

Organizational skills

Education

Bachelor’s degree in Chemistry, Microbiology, Biology, Biochemistry, Pharmaceutical Sciences or related

Tools

TrackWise

Job description

Indotronix Avani Group is seeking a Quality Control Investigation Writer in High Point, NC for a 12-month contract. The role leads and documents GMP-regulated QC investigations, including OOS, OOT, EM, and deviations, coordinating with cross-functional teams to determine root causes and product impact.

We require a Bachelor’s degree in a scientific field and 2+ years in GMP environments, with strong technical writing skills and familiarity with TrackWise.