Chemist, Raw Materials

Chemist, Raw Materials

The Raw Materials Chemist will perform chemical and physical testing on pharmaceutical raw materials (APIs, Excipients and Packaging components).

Responsibilities:

• Perform sampling, physical testing, and chemical testing of raw materials as described in the documented procedure or compendia with minimal supervision in accordance with cGMP guidelines.
• Compile samples for send out testing and maintain associated documentation.
• Maintain laboratory equipment and work areas in good working condition.
• Ensure Raw Material documentation is accurate and up to date and revise as needed (i.e. certificates of analysis, test methods, Standard Operating Procedures)
• Monitor compendia for changes that effect current raw materials testing and procedures.
• Perform assigned calibrations and preventative maintenance for equipment in the laboratory.
• Recognize and troubleshoot equipment issues.
• Recognize and investigate Out of Specification results, Out of Trend results and deviations in accordance with cGMP guidelines and report results to supervisor.
• Audit laboratory documentation.
• Assist with training of Raw Material Analysts and temporary personnel.
• Responsible for laboratory systems as assigned (i.e. logbooks, calibrations, standards)
• Perform new material verifications with minimal supervision.
• Assist with method validations.
• Assist with installation of new laboratory equipment.
• Accurately maintain notebooks and files compliant with current GMPs and internal Standard Operating procedures.
• Observes all safety procedures and regulations.
• Other job-related tasks as required

Experience, Education, and

Skills Required:

• Bachelor or Master's degree in Chemistry or related field
• 0-2 years' experience for a Chemist I, 3-5 years' experience for a Chemist II; working in a Quality Control, Raw Materials or Research and Development Laboratory, preferably in the pharmaceutical industry; years' + type of experience and Education level will determine level
• Working knowledge of laboratory procedures, equipment, instrumentation, safety procedures and laboratory practice
• Working knowledge of current Good Manufacturing Practices (GMPs)
• Proficient in Microsoft Excel, Word. Microsoft Access experience a plus
• Basic knowledge of technical writing coupled with good oral communication skills.

Physical Demands:

• Stand, walk, push, pull, twist, reach overhead, and bend to the floor.
• Occasionally move items or equipment weighing up to 50 pounds – potential to handle heavier materials with mechanical assistance.
• Occasionally required to climb ladders and/or steps to reach equipment.
• Reading precision measuring equipment, machine dials, gages, and thermometers; must be able to observe fine details utilizing a microscope.
• Must have ability to wear a respirator in order to work with chemicals of a specified potency level

Adare Pharma is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital & veteran status.

Principals Only No Agencies Or Third Parties