NEPHRON SC, LLC

Compensation

Full Description

Description Job Purpose: Provide real-time QA oversight across BFS and aseptic manufacturing to ensure compliant, accurate, and efficient execution of GMP production activities. Ensure full adherence to FDA, cGMP, and internal Quality System requirements through on-floor presence, documentation oversight, and cross functional coordination. Lead, develop, and support the Quality Operations team, promoting a strong culture of compliance, ownership, and right-first-time performance. Drive operational and quality excellence through proactive issue identification, timely decision-making, and effective cross functional partnerships. Support continuous improvement initiatives to strengthen documentation practices, reduce deviations, and enhance audit readiness. Oversee and support Visual Inspection operations Essential Duties and Responsibilities: Provide daily oversight of BFS and aseptic operations, including observation of critical process steps, cleanroom behaviors, and adherence to established parameters. Ensure batch execution aligns with cGMPs, SOPs, and documentation standards; review in-process documentation for accuracy, completeness, and right the first time expectations. Maintain a high state of inspection readiness for regulatory, state, and customer audits through routine walkthroughs, documentation checks, and reinforcement of quality behaviors. Provide QA oversight of Facilities and Engineering work performed in or impacting GMP areas, including documentation verification and approvals in validated electronic systems. Support deviation investigations, including documentation of events, fact gathering, root cause analysis, and CAPA implementation. Ensure timely and accurate review of batch records, logbooks, and supporting documentation; identify trends and error patterns for corrective action. Collaborate with respective departments to resolve realtime issues and support continuous improvement of processes, documentation, and material flow. Provide coaching, mentoring, and training for QA and Production personnel regarding documentation accuracy, procedural compliance, and GMP expectations. Develop, monitor, and report key quality metrics such as right the first time, documentation errors, and operational compliance trends. Promote contamination control, aseptic discipline, and strong adherence to cleanroom requirements across all shop floor operations. Communicate quality issues and significant observations promptly to Quality leadership to support timely decision-making and escalation when required. Ensure visual inspectors are properly trained and qualified for operations. Verify adherence to approved inspection procedures and support development and maintenance of work instructions and defect libraries. Perform any other duties related to the Quality Assurance function as necessary or assigned. Job Specifications and Qualifications: Knowledge & Skills: Strong understanding of cGMPs, FDA regulations, Quality Systems, and documentation requirements supporting sterile manufacturing. Knowledge of sterility assurance concepts, cleanroom behavior, and contamination control within aseptic or BFS environments. Experience reviewing batch records, assessing documentation accuracy, and supporting deviation and CAPA processes. Ability to lead, coach, motivate, and develop Quality Operations personnel. Strong analytical, problem-solving, and root cause analysis skills. Effective communication, technical writing, and cross-functional collaboration capabilities. Proficiency with Microsoft Word, Excel, PowerPoint, and electronic Quality Systems. Strong attention to detail, time management, and organizational skills. Education/Experience: Bachelor of Science degree preferred. 5+ years of Quality Assurance experience in sterile pharmaceutical manufacturing preferred. 3+ years of supervisory or management experience in a GMP environment preferred. Experience supporting regulatory inspections and interacting with auditors. Familiarity with BFS or aseptic production environments strongly preferred. Working Conditions / Physical Requirements: Requires routine walking through production areas, standing, bending, typing, and lifting up to 40 lbs. Requires gowning and work within cleanroom environments.