Downstream Manufacturing Associate

QUALITY CONSULTING GROUP, a leader inthe 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:

• Work in a dynamic production environment atsite supporting development, clinical, and launch activities.
• Under general supervision, employee will perform operations in the Manufacturing area.
• Operations will be performed according to Standard Operating Procedures (SOPs).
• Performing in-process sampling of equipment and operating analytical equipment
• Performing washroom activities: clean small- and large-scale equipment used in production activities.
• Maintaining an organized and clean workspace
• Initiating quality reports
• Drafting and revising documents (SOPs, MPs)
• Assisting in the review of documentation for assigned functions (equipment logs, batch records)
• Working around high-pressure systems and occasionally work around heavy equipment.
• Hands on work using large scale purification equipment and managing purification samples.

Qualifications:

• Bachelor's Degree inLife Sciences or related area
• 4 years of related experience
• Experience in Set-up, cleaning, and sanitization of various manufacturing equipment
• Experience in preparing buffers/media per defined manufacturing procedures (MPs) and standard operating procedures (SOPs)
• Knowledge ofGMP documents (SOPs, MPs) with strict adherence to safety and compliance
• Ability to workin a manufacturing plant environment wearing steel toe shoes, lab coat, safety glasses and gloves when performing all work.
• Must be able to work multiple shifts at 3 month intervals (Day and swing shift)
• Start on day shift (7:30am – 4:30am) and rotates to swing shift (2:30pm – 11:30pm) on a 3-month rotation