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Quality Control Analyst I
Celldex Therapeutics
- Fall River, MA 02720
On-site
$66,413 - 86,250/ Year
Bio-Pharma
Quality
- Posted on:
Job Description
Summary
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.
Education
Degree
Associate/BachelorSpecialization
Biology/ChemistryExperience:
0-2 yrs
- Skills:
- Environmental Monitoring (EMP)
- Cleanroom Monitoring (ISO 5/7/8)
- Aseptic techniques
- USP/EP Purified Water Sampling
- Microbial Bioburden Testing
- Raw Material Sampling & ID Testing
- Job Type:
- Full-time
- Shift Type:
- 8 hour shift
- Monday to Friday
- Day shift
Compensation
- Benefits:
- 401K
- 401K Match
- Medical, Dental, Vision
- Additional:
- Base Salary
Job ID:
CGXP_26_23912