Quality Control Analyst at Delcath Systems Inc – Queensbury, New York

POSITION SUMMARY

The QC Analyst will participate in product release testing and research activities related to product development/ new indications.

The incumbent must demonstrate a high level of involvement in continuous improvement activities to ensure the highest standards are maintained. The candidate must possess the ability to solve practical problems and deal with a variety of situations in a fast-paced environment.

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.

• Assist with the end-to-end process of batch release testing which includes but not limited to experimental set-up, preparation of drug solution, sample collection, data review/ analysis, decontamination, bio-hazard disposal process, and others.
• Assist with equipment calibration and PM services, where applicable.
• Comply with GDPs for maintenance of data and records. Maintain knowledge of organizational SOPs and apply where needed.
• Assist with R&D activities including preparing standards/ reagents/ solutions, inventory, chemical disposal, analysis of samples using LC-MS on a routine basis.
• Assist with product development engineering projects.
• Responsible for laboratory upkeep and maintenance.
• Assist Analytical chemist in planning and organizing of R&D lab activities to meet set project deliverables.
• Comprehend, and effectively communicate technical data across cross-functional team.

SUPERVISORY RESPONSIBILITIES

None.

QUALIFICATIONS

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

EDUCATION and/or EXPERIENCE

• A minimum of bachelor’s degree in chemistry or life sciences is required.
• Knowledge of analytical concepts and minimum 3 years’ experience working in an analytical lab using HPLC, GC,MS or other analytical instrumentation.
• Minimum 3 years’ experience working in analytical chemistry in a regulated industry such as medical device, pharmaceutical or FDA registered laboratory.
• Ability to effectively identify/ trouble shoot instrument related technical problems.
• Ability to read, understand, and conduct USP/NF raw materials official monograph testing is required.
• Ability to read and understand peer reviewed journals/ research articles.
• Experience with data compilation and reporting which includes development of data presentation abstracts.
• Must possess strong analytical problem solving and process skills, and be computer proficient in EXCEL, Word, etc.
• Must be willing to learn any new applications as needed.
• Must be team oriented, with the ability to work well with diverse cross-functional teams.
• Must possess strong verbal and written communication skills.
• Must possess ability to apply common sense understanding to carry out instructions in written, oral, or schematic form.

LANGUAGE SKILLS

Ability to read and interpret documents such as technical journals, safety rules, operating and maintenance instructions, and procedure manuals. Ability to write routine reports and correspondence. Ability to speak effectively with employees and outside organizations.

MATHEMATICAL SKILLS

Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals. Ability to compute rate, ratio, and percent and create and/or interpret spreadsheets and graphs.

PHYSICAL DEMANDS

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is regularly required to sit. The employee is frequently required to use hands to finger, handle, or feel and reach with hands and arms; and is subject to repetitive motions of the wrists, hands, and/or fingers. The employee must occasionally lift and/or move up to 10 pounds. Specific vision abilities required by this job include close vision, distance vision, peripheral vision, depth perception, and ability to adjust focus.

WORK ENVIRONMENT

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is occasionally exposed to moving mechanical parts, heat, airborne particles, moderate noise and outside weather conditions.