Quality Control Analyst I

About Celldex

Celldex is pioneering new horizons in immunology to deliver life-changing therapies. We are relentless in our pursuit of novel antibody-based treatments that engage the human immune system and directly affect critical pathways to improve the lives of patients with allergic, inflammatory and autoimmune disorders. We have built a culture where innovative and talented people thrive - focusing a significant effort on attracting and retaining passionate and motivated employees who want to play a role in helping people with serious health conditions and who see this effort as personally rewarding. In our highly entrepreneurial environment, employees are empowered and the opportunity for professional development occurs every day.

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.