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Quality Control Laboratory Analyst

Noramco, Inc.
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Quality Control Laboratory Analyst 

Regular full time position 2nd shift (3 pm to 11 pm) eligible for shift differential

Noramco is a leading specialty active pharmaceutical ingredient (API) development and manufacturing company that supports the advancement of opioid and non-opioid products in a range of therapeutic applications. Founded in 1979, the company is headquartered in Delaware and maintains operations around the world.

Specialists in controlled substance development and manufacturing, Noramco is a partner to the pharmaceutical industry:

– Delivering DEA-compliant security and production capacity, from kilos to multi-ton supply
– High-purity controlled substances from narcotic raw materials
– Formulation-friendly particle size grades and extended technical packages
– Supporting world-class supply security of controlled substances, from schedule I to schedule III

https://www.noramco.com/

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JOB Summary

Under direct supervision learns to conduct chemical and physical laboratory tests and analyze raw materials, in-process samples, intermediates, final and stability products, to ensure compliance with standards by performing the following duties.

ESSENTIAL DUTIES AND RESPONSIBILITIES

  • 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 Active Pharmaceutical Ingredients to determine stability, purity, chemical content, and other characteristics. Follows standardized test methods or standard operating procedures. Documents all pertinent analytical data and communicates status of test results.
  • Maintains procedural requirements regarding chain of custody of all samples submitted to the laboratory.
  • Assures accurate and timely input of QC data to information systems: e.g.: SAP, Intellitrack, etc.
  • 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.
  • Demonstrates focus and attention to details (i.e. 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.
  • Provides training to other analysts as assigned.
  • Must be available for overtime work on a scheduled or emergency basis.
  • Is available for other duties as required.

ADDITIONAL POSITION REQUIREMENTS

  • 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 turnover 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 Quality systems and thorough ability to learn 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 safety, environmental and quality 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, in addition to 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.

SUPERVISORY RESPONSIBILITIES None

QUALIFICATIONS

EDUCATION and/or EXPERIENCE

· Minimum requirements include an Associates degree (A.A.) 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 (B.A./B.S.) 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.

LANGUAGE SKILLS

  • Read and interpret documents such as safety rules, operating and maintenance instructions, and standard operating procedure documents.
  • Write routine reports, business correspondence, and standard operating procedure documents.

MATHEMATICAL SKILLS

  • Work with mathematical concepts such as calculating solution concentrations (e.g. volume %, weight %, normality, and molarity).
  • Apply concepts such as fractions, percentages, ratios and proportions to practical solutions.
  • Apply mathematical operations to such tasks as frequency distribution, determination of test reliability and validity, analysis of variance, corollary techniques, sampling theory, and factor analysis.

REASONING ABILITY

  • Define problems, collect data, establish facts, and draw valid conclusions (e.g. root cause analysis).
  • Interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.

OTHER SKILLS ABILITIES OR 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.

PHYSICAL DEMANDS

  • 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 is occasionally required to sit; reach with hands and arms; climb or balance; stoop, kneel, crouch, or crawl; and smell.
  • The employee must frequently lift and/or move up to 10 pounds, and may occasionally lift and/or move up to 25 pounds.
  • Specific vision abilities required by this job include close vision, color vision, and ability to adjust focus.
  • Must be able to qualify for respiratory protective equipment use.

Noramco is an equal opportunity employer. Qualified applicants will be considered without isysregard to race, color, religion, creed, sex, sexual orientation, gender identity, marital status, national origin, age, veteran status, disability or any other protected class.