Posting ID: JP-002664616
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.
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
quality control lab, calibration, validation testing, excel data entry
Additional Skills & 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
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.
Recruiter: Jean Chambers
Phone: (410) 579-3072