Jobs at Resilience

This position is responsible for executing Quality Assurance (QA) activities that directly support manufacturing processes within the Drug Product Process Execution Team (DPPET), as well as in assigned areas outside of the Process Execution Teams (PETs). Key activities include, but are not limited to, batch record review, documentation management, continuous improvement initiatives, and practical problem-solving to ensure compliance and operational excellence.

Work schedule: Monday - Friday; 5pm - 1:30am (Sterile Operations, nights, West Chester, OH).

• Maintain a high level of understanding of relevant production processes and quality systems
• Perform QA review of batch records and associated documentation to ensure accuracy and compliance
• Collaborate with and influence other professionals across the organization to ensure consistent application and execution of key quality standards
• Responsible for performing department training for peers, mentoring junior Quality Associates, and maintaining the batch review tracker
• Execute and lead QA processes, including batch record review and quality issue resolution, to support timely product and documentation flow in alignment with site objectives
• Partner with applicable site support groups on projects (capital and non-capital) that impact the PET/assigned area, and proactively ensure GMP compliance during the planning, execution, and closeout phases of these projects
• Work collaboratively with PET/assigned area personnel to drive process improvements and conduct risk assessments; benchmark internal and external QA practices to identify innovative and efficient solutions
• Monitor evolving regulatory requirements and recommend implementation strategies to site leadership
• Support data analysis and the development of reports related to quality metrics and key performance indicators

Minimum Qualifications

• Prior experience in the pharmaceutical industry or Quality Assurance
• Demonstrated knowledge of cGMPs and Quality Systems
• Strong attention to detail
• Problem-solving skills
• Ability to train and mentor peers
• Ability to gown aseptically and successfully complete aseptic gowning qualification
• Excellent oral and written communication skills
• Strong ability and motivation to learn

Preferred Qualifications

• Bachelor's degree: Master's degree in Quality/Regulatory Affairs is desirable
• Previous experience in a Lean, process-centric organization with emphasis on continuous improvement
• Multi-site / multi-functional experience
• Advanced experience in Quality Assurance