MCS Manufacturing Associate

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:        

• The plant manufactures drug substance at all phases of clinical trials through commercial production.
• Work in a dynamic production environment at site supporting development, clinical, and launch activities.
• Under general supervision, employee will perform operations in the Manufacturing area.
• Preparing buffers/media per defined manufacturing procedures (MPs) and standard operating procedures (SOPs)
• Equipment set up, operating process equipment, buffer/media prep, equipment cleaning, sampling of in-process product pools and sample management in electronic sample management system.
• Analytical testing to support production, including pH, cell counting, protein concentration, etc.
  Identify and recommend improvements to operations and implement after approval.
• Following GMP documents (SOPs, MPs) with strict adherence to safety and compliance
• Performing and monitoring critical processes with the ability to perform basic troubleshooting.
• Performing in-process sampling of equipment and operating analytical equipment

Qualifications:

• Bachelor's Degree in Life Sciences or related area
• 2 years of related experience
• Chromatography Experience - At least 1 year experience preferred - (protein separation)
• Biotech Process Development or Manufacturing experience - downstream purification area (process development, clinical manufacturing, protein purification, cell culture)
•  Large Scale processing, buffer prep or media prep experience.
• Starting on the day shift: 7:30am - 4:30pm for 12 weeks
  after which they will move to the 2:30pm to 11:30pm for 12 week rotation
• Available to work various shifts (day, swing, graves, weekends, holidays, 5x8hrs, 4x10hrs, 3 or 4x12hrs) as dictated by the production schedule.

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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