JT198 - ASSOCIATE MANUFACTURING bei Quality Consulting Group

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:        

• Completing operations on the floor in Services area and are responsible for the manufacturing of cGMP (current Good Manufacturing Practices) drug substance.
• Completes work in accordance with established cGMP procedures and policies (Standard Operating Procedures [SOPs], Manufacturing Procedures [MPs], Job Hazard Analysis [JHAs], Code of Federal Regulations [CFR] with strict adherence to safety and compliance.
• Ensure proper gowning and aseptic techniques are always followed
• Perform hands-on operation including set-up, cleaning, sanitization, monitoring of equipment and assigned area
• Buffer and Media preparation and transfer
• Weigh and dispense of materials to be used in the preparation of Buffers and Medias
• Complete washroom activities: cleaning equipment, small to large scale, use in production activities
• Run and monitor critical process per assigned procedures
• Perform documentation for assigned function (i.e., equipment logs, EBRs)

Qualifications:

•  High school diploma / GED + 1 year of manufacturing and/or other regulated experience or associate’s degree
• Completion of NC Bio Works Certificate Program
• Experience in a regulated industry such as biotechnology or pharmaceutical
• Basic understanding of GMP principles
• Strong verbal and written communication skills
• Proficient Microsoft Office skills, and knowledge of other electronic systems such as EBR/MES, Delta V, and Electronic Quality Systems
• Ability to perform assignments with a high degree of focus/attention to detail.
• The initial schedule will be Monday-Thursday or Tuesday -Friday, 10-hour days.
• The schedule will transition to shifts (rotating 2-2-3, 12-hour shifts) upon completion of startup activities and as business needs dictate. 
• 10 candidates for day shift and 10 for night shift needed