Quality Control Analyst II

Responsibilities

• Support environmental monitoring of air, equipment and surfaces in ISO Class 5, 7 and 8 clea rooms, 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.
• Absorb assignments provided by department management and complete them with minimal supervision.
• Assist in training of new employees.
• Database entry for trending programs and data filing.
• Create and revise SOPs and reports.
• Support 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.
• Coincide 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.
• Support shipment of Celldex products for external testing.

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.
• 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.