Quality Control Analyst II: Precision GMP Testing

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

Benefits offered by this job

401(K) plan with employer contribution

Health care benefits

Paid holidays

Vacation

Sick days

Annual discretionary bonus

Long term incentive

Job summary

Celldex Therapeutics, Inc. is seeking a Laboratory QC Analyst to perform routine QC testing, trend data, and SOP maintenance in a GMP environment. Responsibilities include environmental monitoring, sampling of water systems, microbial testing, and supporting investigations.

The role requires a Bachelor’s degree in biology or chemistry, 2+ years in biotech/pharma, and proficiency with instrumentation and Windows software. Flexibility to work varied shifts and weekends may be required.

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 ISO Class 5, 7 and 8 cleanrooms, including in-process and personnel monitoring.
• Support sampling of USP Purified Water system aseptically. Support microbial bioburden and TOC testing on USP/EP Purified Water/equipment cleaning samples.
• Participate in the enumeration and identification of microorganisms isolated in the facility.
• Perform in-process, release, stability, and raw material testing on product and materials according to Product Specifications, SOPs, stability protocols and USP/EP.
• Support growth promotion of media used in production and product testing.
• Participate in Laboratory and Out of Specification Investigations.
• Assist in training of new employees.
• Database entry for trending programs and data filing.
• Create and revise SOPs and reports.
• Participate in compendial method verifications for raw materials and Celldex products.
• Perform inventory and order chemicals and general lab supplies.
• Perform routine preventive maintenance and equipment troubleshooting.
• Coordinate and assist with onsite vendor activities for annual maintenance and equipment repairs.
• Support method transfer from Analytical Development to Quality Control.
• Support critical reagent inventory and requalification program.
• Participate in shipment of Celldex products for external testing.
• Perform other additional job-related duties as required.

Skills

Quality control

Aseptic technique

cGMP

Laboratory instrumentation

Windows software

Education

Bachelor’s degree in Biology, Chemistry or related discipline

Tools

Windows software

Analytical instruments

Job description

Celldex Therapeutics, Inc. is seeking a Laboratory QC Analyst to perform routine QC testing, trend data, and SOP maintenance in a GMP environment. Responsibilities include environmental monitoring, sampling of water systems, microbial testing, and supporting investigations.

The role requires a Bachelor’s degree in biology or chemistry, 2+ years in biotech/pharma, and proficiency with instrumentation and Windows software. Flexibility to work varied shifts and weekends may be required.