Quality Engineering Investigator – GMP CAPA Lead

Osmotica Holdings Corp; Marietta (GA); On-site; USD 90,000 - 110,000; Full time

Job summary

Osmotica Holdings Corp in Marietta, GA seeks a Quality Engineering Specialist 2 to independently lead routine and moderately complex GMP investigations, coordinate CAPA activities, and provide QA review of validation and qualification documents. The role emphasizes evidence collection, clear narratives, and timely follow-up while developing foundational QA skills.

You will facilitate root cause sessions, develop CAPA plans with measurable criteria, track due dates, and support procedures, risk

Qualifications

• Bachelor's degree in a scientific, engineering, pharmacy, or related discipline.
• Typically 3–6 years of GMP experience with at least 2 years in deviation investigation, CAPA, or equivalent.
• Demonstrated ability to independently complete routine investigations and apply risk assessment and structured root cause tools.
• Strong technical writing, facilitation, critical thinking, and cross functional coordination skills; proficiency in quality system records and basic data analysis.

Responsibilities

• Lead investigations from problem definition through full report and response to review comments, coordinating with Manufacturing, Packaging and supporting functions.
• Collect and evaluate records, data, interviews, and process/equipment information; reconcile inconsistencies and identify evidence gaps.
• Prepare impact assessments addressing batches, historical products, future operations, patient risk, and data integrity.
• Facilitate root cause sessions and document evidence for root causes and remaining uncertainties.
• Develop CAPA proposals with owners, measurable criteria, target dates, and effectiveness checks.
• Coordinate investigation and CAPA due dates, follow-up, and escalation per site procedures.
• Analyze deviations and complaint data to identify trends and follow-up actions.
• Support review of procedures, risk assessments, and qualification packets; assist audits with evidence.

Skills

GMP investigations

CAPA processes

Technical writing

Cross-functional coordination

Risk assessment

Education

Bachelor's degree in science/engineering/pharmacy

Tools

Microsoft Office (Word, Excel, Access, Visio)

Job description

Osmotica Holdings Corp in Marietta, GA seeks a Quality Engineering Specialist 2 to independently lead routine and moderately complex GMP investigations, coordinate CAPA activities, and provide QA review of validation and qualification documents. The role emphasizes evidence collection, clear narratives, and timely follow-up while developing foundational QA skills.

You will facilitate root cause sessions, develop CAPA plans with measurable criteria, track due dates, and support procedures, risk