QA Associate II - GMP & Process Quality (Night Shift)

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

Benefits offered by this job

Annual cash bonus

401(k) plan with company match

Healthcare (medical, dental and vision

Paid vacation

Paid holidays

Tuition reimbursement

Job summary

Resilience is seeking a QA professional to support process execution within the Process Execution Team (PET) and in related areas, covering batch release, change control, validation, deviations, SOPs, and regulatory interactions.

Responsibilities include reviewing GMP documentation, batch records, product releases in SAP, investigations, validation plans, and SOPs; collaborating across QA to ensure compliant, efficient processes.

Qualifications

• Experience in pharmaceutical QA, operations, or QA environments.
• Excellent oral and written communication skills.
• Strong motivation to learn and develop in cGMPs.

Responsibilities

• Maintain understanding of production processes and quality systems.
• QA review and approval of GMP documentation affecting activities and facilities.
• Collaborate to ensure consistent application of key quality systems.
• Execute QA processes including batch record review and product disposition.
• Interface with site support groups on projects ensuring GMP compliance.
• Collaborate to drive process improvements and risk assessments.
• Stay abreast of evolving regulatory practices and recommend implementations.
• Contribute to data analysis and reporting of quality metrics.

Skills

Quality Assurance

GMP knowledge

Documentation review

Cross-functional collaboration

Regulatory knowledge

Education

Bachelor's degree in science

Master's degree desirable

Tools

SAP

Job description

Resilience is seeking a QA professional to support process execution within the Process Execution Team (PET) and in related areas, covering batch release, change control, validation, deviations, SOPs, and regulatory interactions.

Responsibilities include reviewing GMP documentation, batch records, product releases in SAP, investigations, validation plans, and SOPs; collaborating across QA to ensure compliant, efficient processes.