JT209 - SPECIALIST MANUFACTURING

QUALITY CONSULTING GROUP, a leader in the pharmaceutical, biotech, medical devices, and manufacturing industry, is looking for a talented, highly motivated and enthusiastic to join our team. In this role, you’ll work with a highly enthusiastic team, contributing to a world-class manufacturing industry in Puerto Rico & USA.

Responsibilities:

• Support the execution of manufacturing 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.
• Serve as a document owner.
• Evaluate, plan, and implement solutions for process improvement opportunities.
• Provide troubleshooting support.
• Provide support of timely execution of the process monitoring quarterly reports, Non-Conformance and CAPA.
• Ensure that all Non-conformances are triaged within the established goal.
• Responsible for authoring investigation reports.
• Responsible for execution of corrective actions.
• Responsible for managing NC/CAPA closure within established goal.
• Monitor and communicate incidents trends.
• Review equipment/system Root Cause Analysis investigations and support trend evaluations.
• Assist with generation of process validation protocols and reports.
• Participate in the NPI process to assess requirements for documentation, materials, training, and equipment modifications.
• Assist manufacturing change owner on CCRB packages impacting the process.
• Participate on the assessment or implementation of special projects or initiatives.

Qualifications:

• Bachelor's degree in science or industrial engineering preferred
• 4 years of Manufacturing Operations experience 
• Experience (manufacturing, process development, or quality assurance) in Biotech or pharmaceutical industry with progressively increasing responsibility and demonstrated experience in compliance, problem solving, critical thinking, project management, and quality systems.
• Proficient and experienced in owning Change Controls.
• Project Management and/or Quality Management skills and experience.
• Demonstrated ability to coordinate and effectively participate in cross-functional project teams and deliver on schedule.
• Proficient with Microsoft Office Tools (Word; Excel; PowerPoint; Project, Teams, Outlook)
• Experience managing quality records (deviations, CAPAs, CAPA-EV, Change Controls, Supplier Investigation Records) using TrackWise, or Vevaa or a comparable quality system
• Experience navigating and executing transaction in SAP (ERP) system.
• Ability to maintain remote working relationships with colleagues and network.
• Available for 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.