Duties/Responsibilities
• Performs quantitative and qualitative analyses for R&D samples, raw materials, packaging components, finished product and stability samples, including documentation and calculations according to relevant methods/SOPs.
• Operates analytical instruments during raw material, in process and finished product testing such as HPLC, Gas Chromatography (GC), UV/Vis, automatic titration, IR, dissolution apparatus etc.
• Performs method development, method validation and/or method transfer activities.
• Prepares method validation/method transfer protocols and reports.
• Assists with Out-of-Specification (OOS) or any other relevant investigation on as needed basis.
• Cleans, maintains and calibrates laboratory equipment according to respective SOPs to ensure compliance with GLP and cGMP.
• Labels, transcribes and records documentation such as report sheets and laboratory notebooks as required by Standard Operating Procedures (SOPs).
• Complies with all Company policies and procedures, including safety rules and regulations.
• Carries out responsibilities in accordance with the organization’s policies, procedures, and state, federal and local laws.
• Meets project deadlines and performance standards as assigned.
• Performs other duties as assigned
Required Qualifications
• Bachelors in Chemistry, Pharmaceutical Sciences, Biology, or equivalent with at least 3 years’ experience in the generic pharmaceuticals industry or equivalent.
• Alternately, Masters in Chemistry, Pharmaceutical Sciences, Biology, or equivalent with at least 2 years’ experience in the generic pharmaceuticals industry or equivalent.
• Proficient in common pharmaceutical laboratory equipment including, but not limited to UV Spectroscopy, HPLC, and GC instrumentation and Dissolution testing.
• GLP/cGMP documentation experience.
• Strong interpersonal and collaboration skills.
• Excellent verbal and written communications skills.