Night Shift QA Associate II — GMP & Process Quality

Resilience; Kentucky; Hybrid; USD 60,000 - 90,000; Full time

Benefits offered by this job

Annual cash bonus

401(k) with company match

Healthcare: medical, dental and vision

Paid vacation & holidays

Tuition reimbursement

Job summary

Resilience is seeking an Associate II, Quality Assurance for the night shift in West Chester, OH. This role ensures QA oversight for batch records, deviations, change controls, and product release within a GMP framework.

The position emphasizes collaboration with PET and other QA teams, data analysis of quality metrics, and adherence to regulatory expectations while offering a strong rewards package and career growth opportunities.

Qualifications

• Experience in pharmaceutical QA or related manufacturing environment.
• Strong communication and documentation skills.
• Familiarity with GMP practices and regulatory expectations.

Responsibilities

• Review and approve GMP documentation that affects QA activities and facilities.
• Perform batch record reviews and product disposition decisions.
• Handle change controls, deviations, and quality investigations.
• Support SOPs, supplier management, and regulatory interactions as needed.
• Collaborate with cross-functional teams to improve quality systems and processes.
• Stay updated on evolving regulatory requirements and industry best practices.

Skills

Quality Assurance experience

GMP knowledge

Excellent communication

Education

Bachelor’s degree

Master’s degree (desirable)

Job description

Resilience is seeking an Associate II, Quality Assurance for the night shift in West Chester, OH. This role ensures QA oversight for batch records, deviations, change controls, and product release within a GMP framework.

The position emphasizes collaboration with PET and other QA teams, data analysis of quality metrics, and adherence to regulatory expectations while offering a strong rewards package and career growth opportunities.