Quality Operations Specialist I: Investigations & Improvement

Bora Pharmaceuticals; Baltimore (MD); Presencial; USD 110.000 - 150.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Competitive salary

Comprehensive health coverage

Retirement savings plan

Paid time off

Professional development

Wellness programs

Employee assistance program

Descripción de la vacante

Bora Pharmaceuticals is seeking a Quality Assurance professional to provide technical quality support for manufacturing processes, equipment, facilities, and product lifecycle activities. The role includes leading investigations and root cause analysis, assessing risk, and supporting change controls and technology transfers.

The position requires strong cGMP knowledge, experience with CAPA programs, and solid technical writing skills.

Formación

• Bachelor’s degree in a technical field and 5–7 years in pharma or CDMO settings.
• Experience leading deviations, investigations, OOS/OOT events, and non-conformances.
• Experience implementing corrective/preventive actions and change controls.
• Knowledge of process validation, equipment qualification, and CPPs.
• Ability to analyze process and product data with statistical tools and trends.

Responsabilidades

• Provide technical quality oversight for manufacturing processes, products, equipment, facilities, and client programs.
• Lead investigations of deviations, complaints, OOS/OOT, and non-conformances using root cause tools.
• Develop and monitor CAPAs to ensure timely closure and sustained effectiveness.
• Perform risk assessments, gap analyses, and impact assessments for changes.
• Review validation, qualification, stability, and process verification docs.
• Support change controls, tech transfers, and new product introductions.

Conocimientos

Root cause analysis

Change control

Deviation investigations

cGMP knowledge

Technical writing

Data analysis

Educación

Bachelor's degree in engineering, pharmaceutical science, life sciences, or technical discipline

Herramientas

Statistical tools

Descripción del empleo

Bora Pharmaceuticals is seeking a Quality Assurance professional to provide technical quality support for manufacturing processes, equipment, facilities, and product lifecycle activities. The role includes leading investigations and root cause analysis, assessing risk, and supporting change controls and technology transfers.

The position requires strong cGMP knowledge, experience with CAPA programs, and solid technical writing skills.