Province: South Australia
Description:
Noramco, Inc., a member of Johnson & Johnson’s Family of Companies, is
recruiting for a QC Lab Analyst, located in Wilmington, DE.
Noramco, Inc. produces a variety of active pharmaceutical ingredients and is a
major worldwide producer of medicinal analgesics, pharmaceutical intermediates
and synthetic fine organic chemicals. It also produces monomers and polymers
for pharmaceutical and medical devices.
Thriving on a diverse company culture, celebrating the uniqueness of our
employees and committed to inclusion, Janssen Research & Development, LLC is
proud to be an equal opportunity employer.
Under direct supervision lea
s to conduct chemical and physical laboratory tests and analyze raw materials,
intermediates, final and stability products, to ensure compliance with
standards by performing the following duties.
* Assures that QC Labs run in a safe, clean, compliant, 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 standard operating procedures.
* Documents all pertinent analytical data and concludes test results.
* Communicates status of test results. Maintains procedural requirements regarding sample control of all samples submitted to the laboratory.
* Reviews accuracy of laboratory data entries.
* 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: SAP, Intellitrack, eLIMS databases, etc.
* Demonstrates focus and attention to details ( Right First Time) in all aspects of the responsibilities.
* Maintains good Right First Time record as defined.
* Maintains detailed records for FDA, DEA, safety and environmental compliance purposes.
* Review SOP’s and other lab documents as necessary.
* Responsible for participating on various projects as assigned.
* Basic understanding of and working knowledge of all instrumental methods related to the lab and quality control testing.
* Performs housekeeping to assure the laboratory is continuously maintained in a safe and orderly condition.
* Participates in daily shift tu
over reporting to other shifts.
* Successfully completes regulatory and job training requirements.
* Remains current in profession and industry trends.
* Makes a positive contribution through demonstration of ability to improve upon current laboratory practices and QS systems and through ability to lea
new skills, procedures and processes.
* 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.
* Understands and responsibly performs duties with attention to quality, safety and environmental matters. Items include; wearing appropriate personal protective equipment, recognizing, reporting and appropriately responding to hazards in the work area (spills/accidents/near misses), properly labeling and storing chemicals, plus all other relevant job requirements.
* Assume responsibility for the environmental effects of work performed and for the identification and recording of environmental problems as they arise.
* Follow all applicable aspects of the site Environmental Management System as it pertains to normal job duties.
* Must be available for overtime work on a scheduled or emergency basis
Qualifications
* Minimum requirements include an Associates degree ( or two (2) years of college or technical school training in wet chemistry and/or basic laboratory functions.
* Must have at least 6 months (up to 2 years) of experience using wet chemistry experience and/or basic laboratory skills.
* Prefer Bachelor’s Degree ( from a four-year college or university in a science related field involving wet chemistry and/or basic laboratory functions.
* An equivalent combination of education and experience may be used to meet the minimum or preferred qualifications.
* Knowledge of chemical concepts and theories.
* Familiarity with chemical manufacturing or similar production processes.
* Familiar with a variety of laboratory equipment, such as GC, HPLC, Karl Fisher, etc.
* Must be able to successfully complete the Lab Analyst Training Program.
* Proficient with Microsoft Office software programs, including MS Outlook.
* Ability to accurately enter data into computer using software applications for data entry and word processing.
* Ability to perform repetitive tasks while maintaining speed of work and attention to detail without loss to production.
* Ability to perform under stress in cases of emergency, critical or hazardous situations.
* Ability to work with others in a team environment.
* Must be able to qualify for respiratory protective equipment use
Primary Location
North America-United States-Delaware-Wilmington
Organization
Noramco, Inc. (6109)
Job Function
Quality Control
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