What are the responsibilities and job description for the JT303 - MANUFACTURING SR. ASSOCIATE position at Quality Consulting Group, LLC?
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