Quality Operations Specialist - Investigations & CAPA

Bora Pharmaceuticals Injectables Inc; Baltimore (MD); In loco; USD 90.000 - 130.000; Tempo pieno

Vantaggi offerti da questo lavoro

Health coverage

Retirement plan

Paid time off

Professional development

Descrizione del lavoro

Bora Bora Pharmaceuticals is a premier CDMO seeking a Quality Assurance specialist to provide technical quality support for manufacturing processes, equipment, facilities, and product lifecycle activities within QA.

You will lead investigations, perform risk assessments, review validation documentation, and support change controls, tech transfers, and continuous improvement, ensuring compliant, reliable operations on-site.

Competenze

• Bachelor's degree in engineering, pharmaceutical science, life sciences, or technical field.
• 5–7 years of pharma/biotech manufacturing ops experience; CDMO or sterile focus preferred.
• Experience leading investigations (OOS/OOT) with structured root cause analysis.
• Knowledge of validation, qualification, change control, and technology transfer.

Mansioni

• Provide technical quality oversight for manufacturing processes and facilities.
• Lead or support investigations of deviations, OOS/OOT, complaints.
• Develop corrective and preventive actions and monitor effectiveness.
• Assist with change controls, tech transfers, and regulatory documentation.

Conoscenze

Root cause analysis

Quality investigations

Statistical data analysis

Documentation quality

cGMP knowledge

Formazione

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

Descrizione del lavoro

Bora Bora Pharmaceuticals is a premier CDMO seeking a Quality Assurance specialist to provide technical quality support for manufacturing processes, equipment, facilities, and product lifecycle activities within QA.

You will lead investigations, perform risk assessments, review validation documentation, and support change controls, tech transfers, and continuous improvement, ensuring compliant, reliable operations on-site.