Description:

The Chemist I is responsible for developing and validating test methods; validating laboratory instruments; conducting lab testing for raw materials, components, in-process materials, finished products, stability, and other samples in accordance with cGMP regulations, regulatory filings, and approved procedures.

Duties /Responsibilities

 Performs quality control release testing for impurity, moisture, dissolution, dosage, etc.

 Reviews testing from other analysts in the quality control

 Documents work in the lab notebook and annexures

 Discards expired reagents and samples after the review has been completed

 Performs validation/verification studies for test methods and cleaning verification

 Prepares reports of testing, analysis, and conclusions

 Prepares spreadsheets, Analytical Report Forms and Certificates of Analysis with quality and diligence

 Creates data packet for drug substance, drug products, product stability and validation/verification studies

 Conducts daily calibration check as needed

 Performs logging of submitted samples as necessary

 Creates and ensures review of specification setting, change controls, and laboratory investigations

 Assists in pulling samples from stability chamber and logging sample as necessary

 Assists as needed to complete data for ANDA submission

 Performs other duties as assigned

Skills:

quality control lab, calibration, validation testing, excel data entry

Additional Skills & Qualifications:

Minimum Qualifications

Bachelor’s Degree in Chemistry, Pharmaceutical, Biology or a science related field or equivalent combination of education and experience are required. Bachelor’s Degree with cGMP Training is preferred.

 Ten-key calculator by touch

 Ability to use general office equipment

 Proficient in Microsoft Word and Excel

 Knowledge of Balance, Dissolution Bathes, AA, and HPLC

 Strong communication skills

 Exceptional attention to detail

 Basic typing skills

 Office environment

 Laboratory environment

Experience Level:

Intermediate Level

About Actalent:

Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We’re supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions.

The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.