Senior QA Specialist – GMP Compliance & Process Quality

Resilience; Blue Ash (OH); In loco; USD 70.000 - 115.000; Tempo pieno

Vantaggi offerti da questo lavoro

Annual bonus program

401(k) with match

Medical, dental, vision coverage

Paid vacation & holidays

Tuition reimbursement

Descrizione del lavoro

Resilience, a blue Ash-based biomanufacturing company, seeks a Senior Specialist in Quality Assurance to oversee inspection, packaging, and release activities in a cGMP environment. The role emphasizes regulatory compliance, documentation accuracy, and continuous improvement across manufacturing operations.

The ideal candidate will bring strong QA leadership, cross-functional collaboration, and a proven track record in pharmaceutical quality systems, investigations, and CAPAs, with a willingness

Competenze

• Extensive QA experience in GMP-regulated environments.
• Strong knowledge of cGMP, regulatory guidance and validation.
• Proven ability to lead cross-functional teams.
• Experience with quality systems and documentation control.

Mansioni

• Provide quality oversight for manufacturing, QA, and release activities.
• Lead investigations, CAPAs, deviations and change controls.
• Review and approve batch records, quality documentation, and validation data.
• Support audits and regulatory inspections, ensuring compliance.
• Collaborate with Manufacturing, MSAT, Engineering and Supply Chain to maintain product flow.

Conoscenze

Quality oversight

Regulatory compliance

Leadership

Cross-functional collaboration

Problem-solving

Formazione

Bachelor’s degree or higher in Pharmaceutical Sciences, Chemistry, Engineering, Life Sciences, or related field

Strumenti

SAP

MAXIMO

CMMS

Electronic QMS

Descrizione del lavoro

Resilience, a blue Ash-based biomanufacturing company, seeks a Senior Specialist in Quality Assurance to oversee inspection, packaging, and release activities in a cGMP environment. The role emphasizes regulatory compliance, documentation accuracy, and continuous improvement across manufacturing operations.

The ideal candidate will bring strong QA leadership, cross-functional collaboration, and a proven track record in pharmaceutical quality systems, investigations, and CAPAs, with a willingness