Quality Assurance Specialist

Commissioning Partners LLC.; Ohio; Sur place; USD 70 000 - 110 000; Plein temps

Résumé du poste

Commissioning Partners LLC seeks a Quality Assurance Specialist to support GMP compliance, quality systems, manufacturing operations, and validation activities in Ohio.

You will review GMP documents, lead deviations and CAPA, handle change controls, and ensure data integrity in line with FDA and cGMP standards while collaborating with Manufacturing, QC, Engineering, Validation, and Regulatory teams.

Bachelor’s degree in Life Sciences or related field with 4+ years pharma GMP experience preferred.

Qualifications

• Bachelor’s degree in Life Sciences, Pharmacy, Engineering, or related field.
• 4+ years of pharmaceutical/biotech GMP experience.
• Strong knowledge of QA systems, deviations, CAPA, change control, validation, and regulatory compliance.

Responsabilités

• Review and approve GMP documentation, SOPs, protocols, reports, and batch records.
• Lead/support deviations, investigations, CAPA, change controls, and root cause analysis.
• Review and approve validation and qualification documentation.
• Support audits, inspections, risk assessments, and GMP compliance activities.
• Ensure compliance with FDA, cGMP, data integrity, and company quality requirements.
• Partner with Manufacturing, QC, Engineering, Validation, and Regulatory teams to resolve quality issues.

Connaissances

QA systems

Deviations

CAPA

Change control

Validation

Regulatory compliance

Formation

Bachelor's degree in Life Sciences

Description du poste

We are seeking a Quality Assurance Specialist to support GMP compliance, quality systems, manufacturing operations, and validation activities.

Key Responsibilities:

• Review and approve GMP documentation, SOPs, protocols, reports, and batch records.
• Lead/support deviations, investigations, CAPA, change controls, and root cause analysis.
• Review and approve validation and qualification documentation.
• Support audits, inspections, risk assessments, and GMP compliance activities.
• Ensure compliance with FDA, cGMP, data integrity, and company quality requirements.
• Partner with Manufacturing, QC, Engineering, Validation, and Regulatory teams to resolve quality issues.

Required Qualifications:

• Bachelor’s degree in Life Sciences, Pharmacy, Engineering, or related field.
• 4+ years of pharmaceutical/biotech GMP experience.
• Strong knowledge of QA systems, deviations, CAPA, change control, validation, and regulatory compliance.