GMP QC Microbiology Associate

GenScript Biotech Corp.; New Jersey; On-site; USD 55,000 - 70,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k) with company match

Paid parental leave

Paid time off

Flexible spending account

Health savings account

Life and AD&D insurance

Job summary

GenScript Biotech Corp. in New Jersey is seeking a GMP QC-Microbiology Lab professional with a proven track record in development and transfer of processes for GMP manufacturing of clinical trial materials.

You will set up, develop, and maintain QC microbiology lab functions, perform environmental monitoring, mycoplasma testing, and other assays, while ensuring cGMP compliance and high-quality documentation in a fast-paced CDMO environment.

Qualifications

• Master’s degree with 1 year of relevant work experience, or Bachelor’s degree with 3 years of relevant work experience.
• Degree in Microbiology, Molecular Biology, Biochemistry, or related scientific field.
• Experience with Environmental monitoring, cleanroom activities.
• Experience in Mycoplasma testing or other cell culture and viral assays.
• Experience with GMP documentation, procedures, test methods, protocols, reports.

Responsibilities

• Assist in the set-up, development and maintenance of a GMP QC-Microbiology Lab.
• Participate in EMPQ, cleanroom validation, and associated activities/documents.
• Responsible for following cGMP in carrying out functions related to QC testing.
• Functions may include, but not limited to, Environmental Monitoring, Plate Reads, Water Testing, Gas Testing, Gram Staining, Growth Promotion, Bioburden, Gowning Qualifications and other QC-Microbiology activities.
• Testing of compounded sterile and non-sterile pharmaceuticals
• Assist laboratory personnel in daily activities to maintain quality and compliance with SOPs, cGMP protocols, and safety standards.
• Conduct mycoplasma testing and various virology and microbial assays
• Demonstrate the ability to learn new skills and achieve proficiency
• Support optimization initiatives to improve QC department.
• Perform other duties, as assigned based on business needs.

Skills

Environmental monitoring experience

Mycoplasma testing experience

GMP documentation experience

Problem solving

Education

Master’s degree in Microbiology or related field

Bachelor’s degree with 3 years relevant experience

Job description

GenScript Biotech Corp. in New Jersey is seeking a GMP QC-Microbiology Lab professional with a proven track record in development and transfer of processes for GMP manufacturing of clinical trial materials.

You will set up, develop, and maintain QC microbiology lab functions, perform environmental monitoring, mycoplasma testing, and other assays, while ensuring cGMP compliance and high-quality documentation in a fast-paced CDMO environment.