Quality Control Analyst II - Lab Research & Compliance

Celldex; Fall River (MA); On-site; USD 76,000 - 99,000; Full time

Benefits offered by this job

401(k) plan

Health insurance

Paid holidays

Job summary

Celldex in Fall River, MA is seeking a Laboratory Technician to perform routine QC testing, trend data, and create/revise SOPs. The role includes environmental monitoring of air, equipment and surfaces, and sampling of USP Purified Water systems.

Qualifications include a Bachelor's in Biology or Chemistry and 2+ years in Biotech/Pharma, familiarity with cGMP and aseptic technique, and good Windows software skills. Strong communication and teamwork are essential.

Qualifications

• Bachelor’s degree in Biology, Chemistry or related discipline.
• Minimum of 2 years of experience in Biotech/Pharma industry.
• Familiar with standard concepts, practices, and procedures within a quality control organization.
• Experience with various laboratory instrumentation, software, and analytical methods.
• Experience with cGMP and aseptic technique preferred.
• Must have good understanding of Microsoft Windows Software Packages.
• Adaptable to last-minute changes.
• Strong communication and organizational skills.
• Working knowledge of raw material testing, microbiological assays, capillary electrophoresis, ELISA, cell-based assays and/or HPLC testing.
• The ability to work independently and as part of a team.
• Flexibility in schedule for performing testing during weekdays, weekends, and holidays.

Responsibilities

• Support environmental monitoring of air, equipment and surfaces in clean rooms across ISO classes.
• Support sampling of USP Purified Water system aseptically and microbial testing.
• Perform routine QC testing on product and materials per specs.
• Create and revise SOPs and reports; trend data.
• Participate in failures investigations and method verifications.
• Assist training of new employees and data entry for trending programs.
• Coordinate with onsite vendors for maintenance and repairs.
• Perform routine preventive maintenance and troubleshooting of equipment.

Skills

Quality control concepts

cGMP experience

Windows software

Adaptability

Communication

Teamwork

Scheduling flexibility

Education

Bachelor's degree in Biology/C Chemistry or related

Tools

Laboratory instrumentation

Job description

Celldex in Fall River, MA is seeking a Laboratory Technician to perform routine QC testing, trend data, and create/revise SOPs. The role includes environmental monitoring of air, equipment and surfaces, and sampling of USP Purified Water systems.

Qualifications include a Bachelor's in Biology or Chemistry and 2+ years in Biotech/Pharma, familiarity with cGMP and aseptic technique, and good Windows software skills. Strong communication and teamwork are essential.