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:

• Under limited supervision, perform equipment setup, operation, troubleshoot to meet all standards for safety, quality and efficiency.
• Maintain machine uptime, perform any fault clearing and clear stoppages on automated equipment.
• Execute Manufacturing Operations
• Operate and monitor bioprocess equipment (upstream/downstream, formulation, fill/finish depending on area)
• Perform equipment setup, cleaning, sanitization, and changeovers
• Follow electronic batch records (EBRs) and Standard Operating Procedures (SOPs)
• Sample product and perform in-process checks
• Maintain Compliance
• Accurately document activities in electronic systems (e.g., MES, SAP, LIMS)
• Identify, document, and escalate deviations
• Participate in audits and inspections support
• Perform routine checks on process parameters.
• Respond to alarms and minor equipment faults
• Maintain 5S and good housekeeping standards

Qualifications:

• Associate degree (preferred)
• 1-3 year of experience in manufacturing preferably in a FDA regulated environment.
• Hands-on operation, setup, cleaning, and monitoring of manufacturing and process equipment.
• Ability to troubleshoot equipment/system issues and clear stoppages to maintain uptime and quality.
• Basic mechanical aptitude with understanding of automated systems, controls, and electronic batch records/equipment software.
• Teamwork and collaboration across cross-functional groups to support operations and continuous improvement.
• Have a good attendance record and positive attitude
• Initially, 2nd shift 3:30PM - 2:00AM for the first 1-2 months (M-Th)
  Will transition to 2nd shift 2:00PM - 10:30PM (M-F)

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.