GMP Quality Investigator & CAPA Lead

Alora Pharmaceuticals, LLC.; Marietta (GA); On-site; USD 70,000 - 100,000; Full time

Job summary

Alora Pharmaceuticals, LLC. in Georgia is seeking a Quality Engineering Specialist 2 to independently lead GMP investigations, coordinate CAPA activities, and support QA review of validation and qualification documentation.

You will collect evidence, develop clear narratives, perform risk assessments, and drive timely closure while coaching junior staff and ensuring CFR compliance and quality system requirements.

Qualifications

• Bachelor’s degree in a scientific, engineering, pharmacy, or related discipline.
• Typically 3–6 years of GMP experience, including at least 2 years in deviation investigations or CAPA.
• Strong technical writing, facilitation, critical thinking, and cross‑functional coordination.
• Proficiency in Microsoft Office (Word, Excel, Access, Visio).
• Knowledge of FDA CFR basics and quality system records.
• Ability to work with minimal supervision and adapt to changing priorities.

Responsibilities

• Lead investigations from problem definition through final report and response.
• Collect records, data, interviews, and process information; resolve inconsistencies.
• Develop impact assessments for batches, products, and patient risk.
• Facilitate root cause sessions and document evidence.
• Propose CAPAs with owners, criteria, dates, and effectiveness checks.
• Coordinate CAPA deadlines and escalation per procedures.
• Analyze deviations and trends; suggest focused follow-up.
• Assist with validation and qualification documentation packages.

Skills

GMP investigations

CAPA/Deviations handling

Root cause analysis

Technical writing

Cross-functional coordination

Data analysis/basic statistics

Education

Bachelor's degree in a scientific/engineering/pharmacy or related discipline

Tools

Microsoft Office Suite (Word, Excel, Access, Visio)

Job description

Alora Pharmaceuticals, LLC. in Georgia is seeking a Quality Engineering Specialist 2 to independently lead GMP investigations, coordinate CAPA activities, and support QA review of validation and qualification documentation.

You will collect evidence, develop clear narratives, perform risk assessments, and drive timely closure while coaching junior staff and ensuring CFR compliance and quality system requirements.