Quality Assurance Specialist

Position SummaryThe Quality Assurance Specialist will support quality operations across sterile manufacturing, filling, packaging, and inspection activities. This role is responsible for ensuring compliance with established quality standards, regulatory requirements, and current Good Manufacturing Practices (cGMP).The individual will work closely with manufacturing and operations teams to identify quality gaps, resolve process-related issues, support investigations, and drive continuous improvement initiatives. The position requires a strong presence on the production floor and the ability to provide practical quality guidance in a regulated manufacturing environment.Work Schedule: 6:00 AM – 6:00 PM, following a 2-2-3 rotating shift schedule.Key ResponsibilitiesConduct routine quality assessments of manufacturing facilities, personnel, processes, and documentation to ensure compliance with cGMP and internal quality procedures.Provide day-to-day quality guidance to manufacturing and operations personnel, including documentation corrections, troubleshooting, and aseptic processing practices.Promote a strong quality culture by ensuring employees understand and follow applicable quality policies, procedures, and regulatory requirements.Support deviation investigations, incident management, and timely escalation of quality-related events.Participate in root cause analysis (RCA) and provide quality oversight for complex investigations.Review and approve standard operating procedures (SOPs), training documents, forms, and other controlled documentation.Review and approve deviation reports, change controls, and other quality management documentation.Perform batch record reviews to ensure accuracy, completeness, and compliance with established requirements.Collaborate with cross-functional teams to identify process gaps, troubleshoot manufacturing and equipment-related issues, and implement corrective actions.Identify opportunities for continuous improvement and participate in process improvement initiatives.Maintain compliance with applicable regulatory standards, safety requirements, and site quality systems.Required QualificationsBachelor's degree in Life Sciences, Microbiology, Biotechnology, Engineering, or a related technical discipline.Minimum of 4 years of relevant experience in Quality Assurance, Quality Control, or Pharmaceutical Manufacturing/Operations.Previous experience working in the pharmaceutical, biotechnology, or other regulated manufacturing industry.Experience with sterile manufacturing, aseptic processing, or pharmaceutical filling operations is highly preferred.Working knowledge of cGMP guidelines, quality systems, deviation management, change controls, and batch documentation.Experience with root cause analysis, investigation management, and technical documentation.Strong troubleshooting, analytical, and problem-solving skills.Ability to work collaboratively with manufacturing, operations, and quality teams.Strong communication skills with the ability to guide and support cross-functional teams.Demonstrated ownership, accountability, and ability to work independently in a fast-paced manufacturing environment.Preferred QualificationsExperience in sterile pharmaceutical or biologics manufacturing environments.Knowledge of aseptic techniques, cleanroom operations, and contamination control practices.Professional certifications such as Certified Quality Auditor (CQA).Training or certification in Six Sigma, Lean Manufacturing, or continuous improvement methodologies.Experience with quality management systems and electronic documentation platforms.Physical RequirementsAbility to work on the manufacturing floor for extended periods.Ability to stand, walk, bend, stoop, kneel, and move around production areas for prolonged periods.Ability to lift and carry materials weighing approximately 10–35 pounds.Ability to perform aseptic and non-aseptic gowning procedures.Ability to wear required personal protective equipment (PPE), including safety glasses, safety shoes, lab coats, gloves, and other protective equipment as required.Ability to perform routine computer-based documentation and review activities.