|About the Job
Hi-Tech Pharmacal is a speciality pharmaceutical company that develops, manufactures and markets generic and branded prescription and OTC products. We specialize in difficult to manufacture liquid and semi solid dosage forms and offer a wide range of sterile opthamalic, otic and inhalation products.
We realize that our strength and competitive advantage lie with our people. We support our employees in a number of ways to foster a healthy working environment, meaningful work and diversity. Our competitve compensation and benefit programs reflect Hi-Tech Pharmacal's high regard for our employees. We are currently seeking an experienced Chemist to work in our QC Finished Products Laboratory.
In this position you will perform highly technical and advanced chemical duties in the testing of full product line, process validation and samples. You will perform complex analytical procedures, complete pertinent documentation associated with testing and provide leadership and training to junior staff.
Carries out responsibilities in accordance with Hi-Tech's policies and procedures
Complies with all cGMPs, safety requirement and SOPs
Performs difficult analytical techniques such as complex procedures involving multiple extractions, titrations, time reactions and normal phase HPLC with minimal assistance and direction.
Assists in providing training to new staff and on-going training to current staff.
Operates, maintains and troubleshoots all laborary equipment; solves analytical problems that involve trouble-shooting equipment and laboratory methods.
Operates general analytical instruments for all routine testing (HPLC, UPLC, GC, UV, automatic titrator, and IR)
Performs wet chemistry tests (LOD, pH, titration, etc)
Labels, transcribes and records data on approved report sheets, maintains appropriate documentation (records and lab notebooks) of tests and assays, and performs all necessary calculations associated with test analysis as required by SOPs
Prepares written reports including validation studies and recommendations to revise laboratory test methods and SOPs.
Trains all levels of new and current employees and provides direction as needed.
Reviews and audits analytical data from other laboratory personnel
Complies with good housekeeping and safety practices, ensures the collection and proper disposal of hazardous waste from laboratory instruments.
Participates in troubleshooting of analytical test methods and laboratory instruments.
Essential Knowledge, Skills and Abilities:
Excellent understanding of cGMPs, FDA processes and other standard pharma regulatory requirements
Up to date instrumentation skills (UV/IR, HPLC, UPLC, and GC)
Computer applications and programs related to laboratory applications (HPLC, UPLC, FTIR, UV, Lab Calc and GC)
Sampling methods and quality control systems
Quantitative and qualitative techniques
Sample preparation techniques
Spectroscopic techniques and chromatographic systems
Compliance with DEA and site requirements, regarding the handling, use and disposal of controlled substances.
Performs a wide variety of complicated tasks.
BS in Chemistry or related Science
Minimum of 6 years of related laboratory experience in the pharmaceutical industry
|Hi Tech Pharmacal|
State or Province