Qualifications
The essential functions of the role include:Maintaining a visible Quality Assurance presence and confirming processes on the manufacturing floor.Reviewing and approving documentation for quality assurance, including batch records, logbooks, and work orders.Collaborating with the Manufacturing/Operations team to investigate equipment and process-related deviations.Supporting other QA personnel with batch record reviews and material releases.Effectively prioritizing time to balance production timelines with product quality assurance.Making quick decisions during the preliminary evaluation of deviations and implementing corrective actions or escalating issues as necessary.Providing cross-functional support in deviation investigations using root cause analysis and risk analysis tools.Promoting safety expectations and enforcing best practices aligned with SOPs, compliance requirements, and quality guidelines.Utilizing various systems (Veeva, SCADA, BMS, CMMS, LIMS, lab instrument software) to ensure data integrity for site procedures and batch records.Employing technical skills and applied statistics to analyze deviations and identify sources of variability in site processes.
About the job
As a Quality Assurance Associate at INCOG BioPharma Services, you will collaborate closely with the QA Supervisor to uphold site compliance with regulations, ISO standards, and organizational SOPs. Your role will be pivotal in fostering a culture focused on quality, efficiency, and timely delivery. You will actively participate in identifying and addressing operational and quality gaps.
The ideal candidate will possess exceptional interpersonal skills and the ability to build productive, customer-focused relationships with colleagues and internal partners. Your written and verbal communication skills will enable you to convey complex issues clearly to diverse audiences. While thriving in a collaborative team environment, you will demonstrate strong self-management and organizational capabilities to work autonomously. You will appreciate the contributions of process owners and subject matter experts, influencing positive outcomes even without direct reporting authority.