Senior QA Associate - GMP Compliance & Process Improvement

Resilience; Port Union (OH); On-site; USD 70,000 - 115,000; Full time

Job summary

Resilience is a biomanufacturing company seeking a Quality Assurance professional to support manufacturing processes within the Drug Product Process Execution Team and related areas. You will review batch records, manage documentation, and drive continuous improvement while ensuring compliance.

The role requires strong attention to detail, knowledge of cGMPs, and the ability to train peers, in a fast-paced environment at our West Chester, OH site.

Qualifications

• Experience in the pharmaceutical industry or Quality Assurance.
• Knowledge of cGMPs and Quality Systems.
• Strong attention to detail and problem-solving skills.
• Ability to train and mentor peers.
• Gown aseptically and complete gowning qualification.

Responsibilities

• Maintain understanding of production processes and quality systems.
• Perform QA review of batch records and documentation.
• Collaborate to ensure consistent application of quality standards.
• Train peers and mentor junior Quality Associates.
• Lead QA processes and resolve quality issues.
• Partner with site groups on projects affecting PET areas and ensure GMP compliance.
• Work with PET personnel to drive process improvements and perform risk assessments.
• Monitor regulatory requirements and develop quality metrics reports.

Skills

Quality Assurance

cGMPs

Attention to detail

Training & mentoring

Communication skills

Problem-solving

Education

Bachelor's degree

Master's degree in Quality/Regulatory Affairs

Job description

Resilience is a biomanufacturing company seeking a Quality Assurance professional to support manufacturing processes within the Drug Product Process Execution Team and related areas. You will review batch records, manage documentation, and drive continuous improvement while ensuring compliance.

The role requires strong attention to detail, knowledge of cGMPs, and the ability to train peers, in a fast-paced environment at our West Chester, OH site.