QA Associate II: GMP Quality & Process Impact

Resilience; Olde West Chester (OH); On-site; USD 60,000 - 90,000; Full time

Benefits offered by this job

Annual bonus

401(k) match

Health care

Paid vacation

Paid holidays

Tuition assistance

Caregiving support

Job summary

Resilience is a technology-focused biomanufacturing company seeking a QA professional to oversee all QA activities that support process execution, including batch release, change control, documentation, validation, deviations, SOPs, supplier and distribution center management, and regulatory interactions.

Key responsibilities include reviewing GMP documentation, ensuring QA processes flow smoothly, and collaborating with site teams to maintain compliance.

Qualifications

• Experience in the pharmaceutical industry, operations environment, or Quality Assurance is required.
• Excellent oral and written communication skills.
• Strong ability and motivation to learn.

Responsibilities

• Maintain understanding of production processes and quality systems.
• Review and approve GMP documentation affecting activities and facilities.
• Collaborate with Quality professionals to ensure consistent QA practices.
• Execute QA processes including batch record review and product disposition.
• Interface with site support groups on projects to ensure GMP compliance.
• Support process improvements and risk assessments across PET/areas.
• Stay updated on regulatory compliance and implement strategies.

Skills

QA Experience

Communication Skills

Fast Learner

Education

Bachelor's degree

Master’s in science desirable

Job description

Resilience is a technology-focused biomanufacturing company seeking a QA professional to oversee all QA activities that support process execution, including batch release, change control, documentation, validation, deviations, SOPs, supplier and distribution center management, and regulatory interactions.

Key responsibilities include reviewing GMP documentation, ensuring QA processes flow smoothly, and collaborating with site teams to maintain compliance.