Associate Analyst, Quality Control

At the Janssen Pharmaceutical Companies of Johnson & Johnson, what matters most is helping people live full and healthy lives. We focus on treating, curing and preventing some of the most devastating and complex diseases of our time. And we pursue the most promising science, wherever it might be found.

Janssen Pharmaceuticals, Inc. provides medicines for an array of health concerns in several therapeutic areas, including Cardiovascular, Metabolic, Mental Health, and Pain Management. Please visit www.JanssenPharmaceuticalsInc.com for more information.

We are Janssen. Our mission drives us. Our patients inspire us. We collaborate with the world for the health of everyone in it.

Summary:
Under minimal direction, conducts chemical and physical laboratory tests and analyzes raw materials, intermediates and final product to ensure compliance with standards by performing the following duties.

• Assures that QC Labs run in a safe, clean and environmentally sound manner.
• Tests and analyzes raw materials, in-process samples and products such as chemicals and Active Pharmaceutical Ingredients to determine stability, purity, chemical content, and other characteristics. Follows standardized formulas or experimental procedures. Documents test results. Communicates status of test results.
• Maintain sample control of all samples submitted to the laboratory.
• Reviews peer laboratory data.
• Perform and document stability pulls as assigned.
• Troubleshoots and performs minor maintenance, calibration and repair of laboratory instrumentation.
• Inventories, orders and maintains adequate levels of chemicals and supplies for QC labs.
• Assures accurate and timely input of QC data to information systems: e.g.: ERP, databases, etc.
• Maintains detailed records for FDA, DEA and safety and environmental purposes.
• Review SOP’s and other lab documents as necessary.
• Responsible for sustaining various projects as assigned.
• Provide training to other analysts.
• Carries out duties in compliance with all state and federal regulations and guidelines including FDA, EPA, OSHA and DEA. Complies with all company and site policies and procedures.

• A minimum of a Bachelor’s Degree (B.A./B.S.) from a four-year college or university in a science related field is required.
• A minimum of 1 year of direct work experience using wet chemistry and/or basic laboratory skills is required.
• Knowledge of cGMPs, safety and environmental regulations is required.
• Availability to work both of the following shifts is required: 6am-4:30pm, 2pm-12:30am
• Availability for overtime work on a scheduled or emergency basis is required.
• Experience with HPLC and GC is preferred.
• Experience with FDA and or DEA regulations is preferred.
• Experience with a variety of laboratory equipment, such as: Karl Fisher, etc is preferred.

• While performing the duties of this job, the employee is frequently required to stand; walk; use hands to finger, handle, or feel; and talk or hear.
• The employee will frequently lift and/or move up to 10 pounds, and may occasionally lift and/or move up to 25 pounds.
• Qualify for respiratory protective equipment use.