JT466 - SPECIALIST MANUFACTURING

• Support the execution of manufacturing/quality systems such as non-conformances, process validation, procedures, training, and new product introductions.
• Apply process, operational, scientific expertise, basic compliance knowledge, and analytical and troubleshooting skills to support manufacturing operations.
• May serve as primary production process owner for process support systems and assist with process ownership responsibilities on more complex process systems.
• Initiate, revise, and approve manufacturing procedures, ensuring all documentation reflects current operations and serving as a document owner.
• Evaluate, plan, and implement process improvement initiatives to enhance manufacturing efficiency and compliance.
• Provide technical troubleshooting support for manufacturing processes and equipment-related issues.
• Assist in the development of training materials and support training activities on scientific and technical process aspects.
• Collect, analyze, and evaluate process monitoring data to identify trends and support deviation assessments.
• Ensure non-conformances are triaged within established timelines and quality goals.
• Author investigation reports related to deviations, non-conformances, and process events.
• Execute corrective and preventive actions (CAPAs) and support their implementation.
• Manage non-conformance and CAPA records through closure within established timelines.
• Monitor, analyze, and communicate incident and deviation trends.
• Review equipment and system Root Cause Analysis investigations and support trend evaluations.
• Support the execution of process validation activities and associated documentation.
• Participate in regulatory inspections and support compliance-related activities.
• Support New Product Introductions (NPI) by assessing documentation, materials, training, and equipment modification requirements.
• Assist manufacturing change owners with Change Control Review Board (CCRB) packages impacting manufacturing processes.
• Participate in special projects, continuous improvement initiatives, and cross-functional operational activities.

• Bachelor's degree in Life Sciences, Biology, Chemistry, and/or Engineering.
• Experience in biotechnology pharmaceutical process support, especially on Drug Substance processes, and GMP pharmaceutical manufacturing systems.
• Knowledge in SAP, TrackWise, electronic batch records (PAS/X) and documents management systems (Veeva).
• Detailed technical understanding of bioprocessing unit operations.
• Skilled in performance of GMP production operations.
• Regulatory knowledge and interactions.
• Participate and help lead cross-functional teams.
• Ability to communicate and collaborate with technical and management staff within manufacturing, process development, and quality.
• Basic knowledge of control charting.
• Administrative Shift 

Quality Consulting Group, LLC is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.

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