GMP QC Investigation Writer (Lead)

Lancesoft; High Point (NC); Presencial; USD 28 000 - 50 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Medical Insurance

Dental and Vision Insurance

401k Contributions

Critical Illness Insurance

Voluntary Permanent Life Insurance

Accident Insurance

Other Employee Perks

Resumo da oferta

LanceSoft is seeking a Quality Control Investigation Writer to lead and author investigations in a GMP-regulated pharmaceutical environment in High Point, NC. You will work with QC analysts, QA, Microbiology, Manufacturing, and cross-functional teams to ensure scientifically sound conclusions and compliant documentation.

The ideal candidate holds a Bachelor's in a scientific field and has 2+ years of GMP experience with strong technical writing, data analysis, and regulatory knowledge.

Qualificações

• Bachelor's degree in Chemistry, Microbiology, Biology, Biochemistry, Pharmaceutical Sciences, or a related scientific discipline required.
• Minimum 2 years of experience in a GMP-regulated pharmaceutical, biotechnology, or biologics environment.
• Minimum 1 year of direct experience authoring and leading laboratory investigations within a Quality Control department (preferred).
• Strong working knowledge of FDA regulations, cGMP requirements, and industry guidance related to laboratory investigations.

Responsabilidades

• Lead and author Quality Control laboratory investigations related to Out-of-Specification (OOS), Out-of-Trend (OOT), Environmental Monitoring (EM) excursions, laboratory deviations, and other atypical events.
• Collect, review, and analyze laboratory data, test methods, chromatograms, worksheets, instrument records, and supporting documentation to determine root cause and product impact.
• Facilitate investigation meetings with laboratory personnel and cross-functional stakeholders to gather facts and develop conclusions.
• Perform and document root cause analyses using established investigation tools and methodologies.
• Prepare investigation reports meeting internal procedures and regulatory expectations (FDA, GMP).
• Develop impact assessments on product quality, patient safety, regulatory compliance, and laboratory operations.
• Author and support Deviations, CAPAs, Change Controls; ensure corrective actions and effectiveness checks.

Conhecimentos

Technical writing

Root cause analysis

GMP documentation

FDA regulations knowledge

Data analysis

Cross-functional collaboration

Formação académica

Bachelor's degree in Chemistry, Microbiology, Biology, Biochemistry, Pharmaceutical Sciences, or a related scientific discipline

Ferramentas

TrackWise

Descrição da oferta de emprego

LanceSoft is seeking a Quality Control Investigation Writer to lead and author investigations in a GMP-regulated pharmaceutical environment in High Point, NC. You will work with QC analysts, QA, Microbiology, Manufacturing, and cross-functional teams to ensure scientifically sound conclusions and compliant documentation.

The ideal candidate holds a Bachelor's in a scientific field and has 2+ years of GMP experience with strong technical writing, data analysis, and regulatory knowledge.