Quality Control Analyst — Bohemia, NY
Jerome Stevens Pharmaceuticals, Inc. is seeking to hire full-time Quality Control Analysts with High Performance Liquid Chromatography (HPLC) and Solid Oral Dosage experience at our Long Island facilities.
Primary Responsibilities
Perform in-process and finished product testing of micro-dosed drug products such as assay, uniformity, dissolution and impurity testing.
Perform calibration, qualification and maintenance of laboratory equipment
Job Requirements:
Carries out responsibilities in accordance with the organization’s policies, procedures, and state, federal and local laws
Performs more complex chemistry testing
Operates general analytical instruments during release testing (i.e., HPLC, UV, IR)
Performs wet Chemistry tests on raw materials as required by USP (i.e., LOD, pH, KF, etc.)
Prepares standard and sample solutions as required by test methods
Maintains appropriate documentation (records and lab notebooks) as required by company procedures
Complies with all current Good Laboratory Practices (cGLP), current Good Manufacturing Practices (cGMP) and safety requirements, laboratory Standard Operating Practices (SOPs) and Company policies and procedures
Participates in troubleshooting and review of analytical test methods and laboratory instruments
Perform analysis on intermediate product, finished product, and stability samples
Qualifications:
Knowledge of Current Good Manufacturing Practices (cGMP), Food and Drug Administration (FDA), and other regulatory requirements
Expertise in the latest instrumentation such as: UV/IR, HPLC
Experience in Chemistry and Wet Chemistry
Experience in Sampling Methods, Quality Control Systems, and Sample Preparation Techniques
Expertise in Spectroscopic Techniques and Chromatographic System
Additional Skills:
o Reading, writing and communicating in English (Regulated Documents in English)
o Reading, comprehension and compliance with Company policies and procedures, including safety rules and regulations
o Computer experience a plus
o Accuracy and precision a must
Education:
Minimum Qualifications: Bachelors of Science in Chemistry or related science from an accredited college or university and a minimum of five (5) – eight (8) years of related laboratory work experience; or two or more years of experience as a Chemist II; or an equivalent combination of training and experience.
Full-Time Benefits Include:
Competitive salary (based on experience)
Medical Benefits (including family)
Dental Benefits (including family)
Retirement Planning that includes:
401k
Profit Sharing
Safe Harbor
Accrued Sick and Vacation Time
Annual Bonus (discretionary)