Analytical Scientist, 4581576

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.

BS science degree

A degree in analytical chemistry is preferred.

For more information, Please contact

Akriti Gupta

(973) 967-3409

Morristown, NJ 07960