Job Description

Job Description

Job Description

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:

• Support manufacturing by providing subject-matter expertise for drug substance upstream and downstream processes as process owner (PPO) or Single-use SME
• 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.
• Apply technical process, scientific, operational, and compliance knowledge with analytical troubleshooting skills to support the implementation of new technologies into the plant.
• Demonstrate strategic problem-solving skills and champion continual improvement.
• Support operational readiness of new technologies, equipment, or processes by applying technical process, scientific, operational, and compliance knowledge with project management skills
• Develop/own drug substance manufacturing processes and procedures.
• Draft and revise GMP manufacturing documents (SOPs, Forms). Draft and develop user requirements for new technologies.

Qualifications:

• Bachelor’s degree
• 3 years of Manufacturing or Operations experience
• Ability to successfully communicate complex technical information with internal and external colleagues of varying organizational levels in both presentation and technical writing forms
• Experience leading and managing projects and owning quality records.
• Proficiency in Smartsheets and Database/Quality Management Systems (CDOCS, Trackwise, Spotfire, etc)
• 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.
• Standard shift (M-F 8am-5pm)
• 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.

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