QA Associate II - GMP Batch Release & Compliance

Resilience; Port Union (OH); On-site; USD 60,000 - 90,000; Full time

Benefits offered by this job

Annual bonus

401(k) match

Healthcare plan

Paid time off

Tuition reimbursement

Caregiving support

Job summary

Resilience, a technology-focused biomanufacturing company in Ohio, seeks a QA professional to support process execution. Responsibilities include QA review of GMP documentation, batch release, change control, and deviations within the PET and related areas, ensuring GMP compliance across projects.

You will collaborate with Quality peers, analyze quality metrics, and drive process improvements while maintaining regulatory readiness and documentation integrity in a fast-paced manufacturing

Qualifications

• Experience in pharmaceutical industry, an operations environment, or Quality Assurance.
• Excellent oral and written communication skills.
• Strong ability and motivation to learn.
• Lean/process-centric experience with continuous improvement.
• Multi-site / multi-functional experience.

Responsibilities

• Review and approve GMP documentation affecting PET areas.
• Perform batch record review and product disposition to meet site objectives.
• Manage change requests, deviations, investigations, SOPs and related documentation.
• Collaborate with site support groups to ensure GMP compliance during planning and execution.
• Contribute to data analysis and quality metric reporting.

Skills

Quality Assurance

GMP Documentation

SAP

Data analysis

Education

Bachelor's degree

Master's degree in science

Tools

SAP

Job description

Resilience, a technology-focused biomanufacturing company in Ohio, seeks a QA professional to support process execution. Responsibilities include QA review of GMP documentation, batch release, change control, and deviations within the PET and related areas, ensuring GMP compliance across projects.

You will collaborate with Quality peers, analyze quality metrics, and drive process improvements while maintaining regulatory readiness and documentation integrity in a fast-paced manufacturing