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:        

• Routinely perform moderately-complex to complex processes according to Standard Operating Procedure (SOP). Specific responsibilities include cleaning equipment, steaming equipment, prepping equipment, and performing either upstream, downstream, or solution preparation drug substance GMP manufacturing operations.
• Perform basic troubleshooting and assist in the review of documentation for assigned functions.
• Perform and monitor critical processes, complete routine validation protocols and regularly draft and revise documents such as Manufacturing Procedures, SOP's and technical reports.
• Following Good Manufacturing Practices (GMPs) and applicable regulations from the Code of Federal Regulations (CFRs).
• Reporting any discrepancies to the Team Leader or Production Supervisor to ensure quality standards and safety.
• 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.
• Partnering with cross-functional teams to drive improvement opportunities.
• Ensuring components and products are available for continuous operation.

Qualifications:

• Bachelors Degree in Engineering or Science with no experience OR No Bachelors Degree & 2+ years of experience
• Biotech drug substance manufacturing experience; understanding of measurements, calculations and the metric system
• basic GMP knowledge.
• Understanding of Electric Batch Records, DeltaV, and LIMS.
• Ability to work in a team.
• Shift: Day shift - 7am-7pm (rotating shift, every other week) 2 days on 3 days off etc. (Candidate is expected to work weekends and holidays)

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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