Quality Control Analyst

About the role

We're looking for a motivated and collaborative Quality Control Analyst to join our growing team at Delcath. In this role, you'll have the opportunity to make a meaningful impact while working alongside talented colleagues in a supportive and innovative environment.

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

Responsibilities

• Assist with the end-to-end process of batch release testing, including 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 preventive maintenance services, where applicable.
• Comply with good documentation practices (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, and 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 R&D lab activities to meet set project deliverables.
• Comprehend and effectively communicate technical data across cross-functional teams.

Requirements

• A minimum of a bachelor's degree in chemistry or life sciences is required.
• Knowledge of analytical concepts and a minimum of 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 and troubleshoot 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, including development of data presentation abstracts.
• Strong analytical problem-solving and process skills, and proficiency in Excel, Word, etc.
• Willingness to learn new applications as needed.
• Team-oriented with the ability to work well with diverse cross-functional teams.
• Strong verbal and written communication skills.
• Ability to apply common-sense understanding to carry out instructions in written, oral, or schematic form.

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.
• 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

• Regularly required to sit.
• Frequently required to use hands to finger, handle, or feel and reach with hands and arms; subject to repetitive motions of the wrists, hands, and/or fingers.
• Occasionally required to lift and/or move up to 10 pounds.
• Specific vision abilities required include close vision, distance vision, peripheral vision, depth perception, and ability to adjust focus.

Work Environment

• Occasionally exposed to moving mechanical parts, heat, airborne particles, moderate noise, and outside weather conditions.

Benefits

• Comprehensive health plan.
• 401(k).
• Professional development opportunities.

Pay

$24–$28.85 hourly.