Jt303 - Manufacturing Sr. Associate

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 in a world-class manufacturing industry in Puerto Rico & USA.

Responsibilities:        

• Provide support and subject-matter expertise in a process owner (PO) role for the downstream drug substance operations.
• Support Quality Oversight of analytical testing in manufacturing through comprehensive data capture and analyses using Spotfire.
• Utilize project management skills to lead complex projects or components of projects with successful results.
• Troubleshoot quick issues in a timely manner and run function testing to resolve and improve process performance.
• Write protocols and reports in support of validation, function testing, equipment commissioning and qualification, and change management.
• Own Quality Records, such as CCMS, CAPA, and CAPA-EV.
• Support operational readiness of new technologies, equipment, or processes by applying technical expertise, scientific/operational knowledge, compliance insight and project management skills.
• Develop/own drug substance manufacturing processes and procedures.
• Draft, revise and ensure GMP manufacturing documents (SOPs, FORMS,) align with user requirements for new technologies.

Qualifications:

• Associate degree in engineering or Life Sciences
• 2 years or more experience in Drug substance GMP technical support roles, GMP manufacturing,
• Technical knowledge of downstream operations
• Project management skills
• GMP knowledge and experience in a GMP environment
• Experience running functional test and writing protocols
• Must be able to work in a clean room environment wearing steel toe shoes, full clean room gowning, hairnet and gloves when performing all work while following GMP documents (SOPs) with strict adherence to safety and compliance.
• Dayshift
• Available to work various shifts (day, swing, graves, weekends, holidays, 5x8hrs, 4x10hrs) as instructed by the production schedule to execute function-testing and project tasks with minimal disruption to operations.

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.