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Duration: 6+ month

Job Description:

Under general supervision, performs cGMP laboratory analyses of Finished products and in process materials. Performs stability testing for Finished products. Performs maintenance and calibration of analytical instruments.

Minimum Qualifications:

Bachelor’s Degree in Science or related science field from an accredited college or university and one (1) year related laboratory experience or an equivalent combination of education and experience.

Experience and Skills:

•Usage of GC and HPLC chromatographic equipment, as well as UV/VIS, and FTIR operation methods and techniques.

•Business, scientific and personal computer hardware and software applications.

•Business English usage, spelling, grammar and punctuation.

•Wet Chemistry and Chemistry related to sampling methods, quality control systems, analysis and documentation practices and procedures.

•Knowledge of or ability to learn FDA, cGLP, cGMP, USP, EP and SOP or other applicable regulatory and safety compliance guidelines.

•Performing testing accurately and precisely.

•Responding to routine inquiries from management, employees and regulatory agencies.

•Communicating clearly and concisely, both orally and in writing.

•Managing multiple projects, duties and assignments.

•Establishing and maintaining cooperative working relationships with others.

Essential functions include:

*Carries out responsibilities in accordance with the organization’s policies, procedures and state, federal and local laws.

*Operates general analytical instruments during the testing of finished products using HPLC, UPLC, GC-FID, UV-VIS, FTIR, automatic titrators, Dissolution Apparatus

*Performs physical testing such as viscosity testing, Instron testing, and microscopy .

*Performs wet chemistry tests on samples such as pH, titration, gravimetry and prepares standard, sample, and buffer solutions as required by test methods and performs all necessary calculations associated.

*Labels, transcribes and records documentation such as report sheets and laboratory notebooks as required by SOPs.

*Cleans, maintains and calibrates laboratory equipment to ensure compliance with current Good Manufacturing Procedures (cGMP).

*Meets project deadlines and performance standards as assigned.

*Complies with all Company policies and procedures, including safety rules and regulations

*Performs investigations and troubleshooting of analytical test methods and lab instruments.

*Performs investigation and writes reports on findings, conclusion and identify corrective actions/preventative actions.

*Carries out quantitative and qualitative analyses in support of method comparisons, method transfers, method validations, product in-use study.

*Train junior level scientist and technician and participate in identifying process to improve efficiency in laboratory testing.

*Assist in organizing, staging and pulling samples for stability studies.

*Assist in creating database for stability sample pull, staging sample and test schedules.

*Performs related duties as assigned.

Minimum Qualifications:

Bachelor’s
Degree in Science or related science field from an accredited college or
university and one (1) year related laboratory experience or an
equivalent combination of education and experience.

Experience and Skills:

•Usage of GC and HPLC chromatographic equipment, as well as UV/VIS, and FTIR operation methods and techniques.

•Business, scientific and personal computer hardware and software applications.

•Business English usage, spelling, grammar and punctuation.

•Wet
Chemistry and Chemistry related to sampling methods, quality control
systems, analysis and documentation practices and procedures.

•Knowledge
of or ability to learn FDA, cGLP, cGMP, USP, EP and SOP or other
applicable regulatory and safety compliance guidelines.

•Performing testing accurately and precisely.

•Responding to routine inquiries from management, employees and regulatory agencies.

•Communicating clearly and concisely, both orally and in writing.

•Managing multiple projects, duties and assignments.

•Establishing and maintaining cooperative working relationships with others.

All your information will be kept confidential according to EEO guidelines.