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

• Responsible for providing facility/equipment cleaning, and sanitation, in support of FDA regulated manufacturing areas.
• All work to be completed to assure minimal impact to production while complying with Standard Operating Procedure's (SOP's), Current Good Manufacturing Practices (cGMP's) and Client's regulations.
• Document and review electronic batch records (EBR) appropriate paperwork, daily logs, and work order documentation per Good Documentation Practices. (GDP)
•  Following Good Manufacturing Practices (GMPs) and applicable regulations from the Code of Federal Regulations (CFRs).
• Ensuring quality & compliance through a Right First-Time mentality.
• Receiving and preparing components for use in manufacturing.
• Feeding components into equipment and performing sanitation activities.
• Documenting appropriate paperwork, understanding Overall Equipment Effectiveness (OEE)/performance metrics, and participating in daily performance meetings.
• Use of pallet jacks and manual wrapping of pallets.
• Use of computer systems to support material inventory and electronic batch record.
• Ensuring components and products are available for continuous operation.

• Associate degree and 2 years of experience OR 2 years in a technical school setting with hands-on experience
• Experience with cleaning manufacturing areas/ previous work in a manufacturing area.
• Previous experience working as a technician, in medical device or pharmaceutical industry.
• Aseptic background
• Component preparation.
• Experience in a cGMP Grade 8 or lower environment is preferable. 
• Shift: 7am -4 pm Day shift but possible to move to a split shift of 10/7 in the future.
• Flexibility with schedule, open to overtime.

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.