Artech Information System LLC
Analytical Scientist, 4581576
Artech Information System LLC, East Hanover, New Jersey, us, 07936
Artech is the 10th Largest IT Staffing Company in the US, according to Staffing Industry Analysts' 2012 annual report. Artech provides technical expertise to fill gaps in clients' immediate skill-sets availability.
Job Description
Responsible for performing routine QC Stability testing of finished dosage forms and complaint samples. Experience with HPLC, GC, UV/VIS, Dissolution and other typical QC Analytical instrumentation is required. Verifies / validates US CPO Quality Control data, while monitoring for trends and abnormalities. Reports and acts on data results. Responsible to ensure that established QC procedures are followed. Responsible for following laboratory schedules (as applicable). Responsible to ensure good documentation practices are followed. Responsible for serving on various project teams to fulfill activities as assigned. Individual is capable of independently troubleshooting analytical and instrument problems. Individual is responsible for assuring adherence to Federal (FDA, DEA, EPA), OSHA regulations, cGMP's, SOP's, company policies and procedures. The individual will comply with Good Manufacturing Practices, Health, Safety and Environmental policies and other federal regulations and company policies and procedures. Skills: A minimum of 3 years’ experience working in a cGMP laboratory is required. Knowledge of stability regulation and its application to the industry. Knowledge of cGMPs. (ICH Guidelines) Excellent organizational, communication and leadership skills are required. Excellent interpersonal skills including use of tact, diplomacy, discretion and judgement. Interpretation/Analytical data. The candidate must possess a positive attitude, be flexible/adaptable and able to practice team building and demonstrate good positive people skills. LIMS (Laboratory Information Management) ERP systems preferred. Qualifications
A degree in analytical chemistry is preferred.
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Responsible for performing routine QC Stability testing of finished dosage forms and complaint samples. Experience with HPLC, GC, UV/VIS, Dissolution and other typical QC Analytical instrumentation is required. Verifies / validates US CPO Quality Control data, while monitoring for trends and abnormalities. Reports and acts on data results. Responsible to ensure that established QC procedures are followed. Responsible for following laboratory schedules (as applicable). Responsible to ensure good documentation practices are followed. Responsible for serving on various project teams to fulfill activities as assigned. Individual is capable of independently troubleshooting analytical and instrument problems. Individual is responsible for assuring adherence to Federal (FDA, DEA, EPA), OSHA regulations, cGMP's, SOP's, company policies and procedures. The individual will comply with Good Manufacturing Practices, Health, Safety and Environmental policies and other federal regulations and company policies and procedures. Skills: A minimum of 3 years’ experience working in a cGMP laboratory is required. Knowledge of stability regulation and its application to the industry. Knowledge of cGMPs. (ICH Guidelines) Excellent organizational, communication and leadership skills are required. Excellent interpersonal skills including use of tact, diplomacy, discretion and judgement. Interpretation/Analytical data. The candidate must possess a positive attitude, be flexible/adaptable and able to practice team building and demonstrate good positive people skills. LIMS (Laboratory Information Management) ERP systems preferred. Qualifications
A degree in analytical chemistry is preferred.
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