Quality Control Analyst I

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

Overview

Individual is responsible for performing and understanding all tasks associated with Environmental Monitoring, Purified Water and raw material sampling and testing to support the Fall River Manufacturing facility.

Responsibilities

• Environmental monitoring of air, equipment and surfaces in ISO Class 5, ISO Class 7 and ISO Class 8 clean rooms, including in-process and personnel monitoring.
• Sampling USP/EP Purified Water system aseptically.
• Perform the enumeration and identification of microorganisms isolated in the facility.
• Perform microbial bioburden and TOC on USP/EP Purified Water/equipment cleaning samples.
• Growth promotion of media used in Environmental monitoring and product testing.
• Perform cleanroom gowning qualifications.
• Raw material sampling and ID testing.
• Database entry for trending programs and data filing.
• Participate in SOPs revisions and annual summary reports.
• Perform inventory and order chemicals and general lab supplies.
• Maintain equipment and glassware.
• Perform other additional job-related duties as required.

Qualifications

• Associate’s or Bachelor’s degree in Biology, Chemistry, or related discipline.
• 0-2 years of experience in the biotech / pharmaceuticals industry.
• Experience with cGMP and aseptic technique preferred.
• Adaptable to last-minute changes.
• Strong communication and organizational skills.
• The ability to work independently and as part of a team.
• Flexibility in schedule for performing testing during weekdays, weekends, and holidays.

Compensation Statement

The expected base salary for this position is: $66413.00 to $86250.00. We are committed to compensating employees equitably based on several factors including experience, education, licensure/certifications, skill level, location of the position, and availability of similar talent in a competitive market. Subject to eligibility and applicable plan terms, compensation includes base salary, annual discretionary bonus, long term incentive, 401(K) plan with employer contribution, health care and other insurance benefits (for employee and family), paid holidays, vacation, and sick days. A summary of our benefits can be found on our careers page Celldex is proud to be an equal opportunity employer that strives to foster a culture of diversity, equity, and inclusion. We are committed to promoting a diverse environment through development, recruiting and community outreach.