Quality Assurance Specialist - Sterile Manufacturing

Responsibilities

• Perform daily quality assessments of facilities, personnel, and documentation in classified and non-classified areas.
• Identify errors and deficiencies and ensure quality and cGMP compliance.
• Provide daily guidance to employees on troubleshooting, documentation corrections, and aseptic techniques.
• Promote a strong quality culture by supporting personnel in understanding and applying policies and controls.
• Participate in RAPID event response and provide Quality guidance for deviation events.
• Escalate deviation events to appropriate areas and Quality Management.
• Review and approve procedures, training documents, and forms of moderate to high complexity.
• Review and approve deviations and change controls of moderate to high complexity.
• Participate as the Quality Assurance representative in Root Cause Analysis and deviation investigations.
• Perform quality review of batch records.
• Identify continuous improvement opportunities and participate in process improvement initiatives.
• Collaborate with production leadership to troubleshoot process and equipment issues.
• Capture and analyze data to support troubleshooting and quality decisions.
• Maintain consistent production-floor presence and perform required aseptic and non-aseptic gowning.

Requirements

• Bachelor’s degree required, preferably in Technology, Engineering, Microbiology, or a related field.
• Minimum 4 years of relevant experience in Quality Assurance, Quality Control, Operations, or Manufacturing.
• Pharmaceutical industry experience strongly preferred, particularly aseptic or sterile manufacturing.
• Experience in other regulated environments, such as ISO 9001, may be considered.
• Strong knowledge of cGMP, quality systems, deviation management, change control, and Root Cause Analysis.
• Experience with batch record review, aseptic techniques, process troubleshooting, and equipment troubleshooting.
• Ability to capture and analyze data and identify process issues.
• Strong technical writing skills.
• Able to lead, support, and empower teams and peers.
• Strong ownership, accountability, communication, and problem-solving skills.
• CQA certification and Six Sigma training/certification are a plus.
• Able to stand, walk, bend, kneel, and crouch for prolonged periods.
• Able to lift and move 10–35 pounds and work on the production floor while wearing required PPE.