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 Single-use SME

• Lead sophisticated projects or parts of projects using project management skills.

• Resolve quick issues and execute function tests to troubleshoot and optimize process

• Write protocols and reports in support of validation, function testing, equipment commissioning and qualification, and change management.

• Support New Product introduction and projects through Single Use Systems (SUS) mapping

• Support manufacturing and quality through the SUS defect/leak triage process – perform troubleshooting on the floor, initiate investigation and bring leaks and defects to triage

• Initiate EN/SICAR records and follow process to conclusion, including working with vendors on investigation.

• Maintain up-to-date EN/SICAR/EE trackers and manage or lead small to medium projects

Qualifications:

• Master's degree or Bachelor's related to Engineering or Life Sciences with exposure to GMP.

• 2 years of related experience with exposure to GMP

• Technical Writing skills

• Knowledge of cGMP, Troubleshooting single use materials.

• open to having experience in med device, biotech, pharma, Aerospace (any experience with GMP).

• Proficiency in Smartsheet and excel, Trackwise, visio, pi, SAP, Spotfire.

•  Understanding of SUS technologies

• Presentation experience – presentation to leadership or auditors.

• Available for Day Shift Mon-Fri (weekends if needed and will accommodate hours within the week)

  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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