Pharma QA Specialist - cGMP, CAPA & Batch Review (Contract)

United Pharma Technologies Inc; Ohio; Sur place; USD 51 000 - 73 000; Plein temps

Avantages offerts par ce poste

Health Insurance

401(k) retirement benefits

Résumé du poste

United Pharma Technologies Inc. is seeking a Quality Assurance (QA) Specialist with pharmaceutical industry experience to support quality operations, commissioning and qualification activities, CAPA management, and batch disposition.

The role requires strong knowledge of cGMP and ensuring quality compliance in a pharmaceutical manufacturing environment. Responsibilities include supporting QA activities, reviewing CQ documentation, participating in CAPA investigations, and ensuring batch records

Qualifications

• Pharmaceutical QA experience in a manufacturing environment.
• Hands-on commissioning and qualification (C&Q) activities.
• Strong CAPA, deviation management, and root cause analysis knowledge.
• Experience with batch records review and batch disposition.
• Understanding of cGMP regulations and pharmaceutical quality systems.
• Strong documentation, investigation, and communication skills.

Responsabilités

• Support QA activities in a pharmaceutical manufacturing environment in accordance with cGMP requirements.
• Review and support commissioning and qualification documentation for equipment, utilities, and manufacturing systems.
• Participate in CAPA investigations, root cause analysis, and corrective and preventive actions.
• Review batch manufacturing records and documentation for completeness, accuracy, and compliance.
• Support batch disposition activities by evaluating documentation and ensuring quality requirements are met before batch release.
• Investigate deviations, discrepancies, and nonconformances and assist with timely resolution.
• Collaborate with Manufacturing, Engineering, Validation, and Quality Control teams to maintain inspection readiness.
• Ensure quality documentation complies with procedures, regulatory requirements, and internal standards.

Connaissances

QA experience

CQ activities

CAPA investigations

Root cause analysis

Documentation

Communication

Batch record review

Batch disposition

Investigations

Description du poste

United Pharma Technologies Inc. is seeking a Quality Assurance (QA) Specialist with pharmaceutical industry experience to support quality operations, commissioning and qualification activities, CAPA management, and batch disposition.

The role requires strong knowledge of cGMP and ensuring quality compliance in a pharmaceutical manufacturing environment. Responsibilities include supporting QA activities, reviewing CQ documentation, participating in CAPA investigations, and ensuring batch records