Quality Control Analyst I — Cleanroom & Microbial Testing

Celldex Therapeutics, Inc.; Fall River (MA); On-site; USD 66,000 - 86,000; Full time

Job summary

Celldex Therapeutics, Inc. is seeking an Environmental Monitoring Technician to support the Fall River Manufacturing facility with sampling and testing of purified water, raw materials, and environmental monitoring in ISO cleanrooms.

Responsibilities include aseptic sampling, microbial testing, data entry, and maintaining equipment. The role requires 0-2 years in biotech/pharma, familiarity with cGMP, and ability to work weekdays, weekends, and holidays as needed.

Qualifications

• Associate’s or Bachelor’s degree in Biology, Chemistry, or related discipline.
• 0–2 years of biotech/pharmaceutical experience.
• Experience with cGMP and aseptic technique preferred.
• Adaptable to last-minute changes.
• Strong communication and organizational skills.
• Ability to work independently and as part of a team.
• Schedule flexibility for testing on weekdays, weekends, and holidays.

Responsibilities

• Environmental monitoring of air, equipment and surfaces in clean rooms.
• Sampling Purified Water system aseptically.
• Perform enumeration and identification of microorganisms.
• Microbial bioburden and TOC testing on samples.
• Growth promotion of media for monitoring and testing.
• Perform cleanroom gowning qualifications.
• Raw material sampling and ID testing.
• Data entry for trending programs and filing.
• Support SOP revisions and annual reports.
• Maintain inventory and order lab supplies.
• Maintain equipment and glassware.

Skills

Strong communication skills

Organizational skills

Independent worker

Team collaboration

Education

Associate’s degree in Biology, Chemistry, or related discipline

Bachelor’s degree in Biology, Chemistry, or related discipline

Job description

Celldex Therapeutics, Inc. is seeking an Environmental Monitoring Technician to support the Fall River Manufacturing facility with sampling and testing of purified water, raw materials, and environmental monitoring in ISO cleanrooms.

Responsibilities include aseptic sampling, microbial testing, data entry, and maintaining equipment. The role requires 0-2 years in biotech/pharma, familiarity with cGMP, and ability to work weekdays, weekends, and holidays as needed.