Job Description

Job Functions:

• Conduct routine chemical testing of finished products and stability samples using internally developed and compendial test methods.
• Perform validated analytical testing of pharmaceutical finished products for strength, impurities, identity, and other characteristics using HPLC, dissolution, and wet chemistry techniques.
• Identify and promptly report out-of-specification (OOS) results, unexpected results, and non-routine analytical or product issues.
• Perform daily instrument calibrations and verifications as required.
• Accurately document testing procedures, analytical results, and observations in accordance with established laboratory procedures and systems.
• Prepare test solutions, including diluents and mobile phases.
• Clean and maintain laboratory work areas and instrumentation.
• Perform all duties in compliance with Standard Operating Procedures (SOPs), current Good Manufacturing Practices (cGMPs), Good Laboratory Practices (GLPs), and safety guidelines.
• Maintain compliance with company and facility quality standards.

Education and Experience:

• Bachelor's degree or higher in a physical science, preferably Chemistry.
• 1–2 years of experience performing chemical testing using chromatographic techniques such as HPLC or GC.
• Working knowledge and hands-on experience with HPLC instrumentation required.
• Equivalent combinations of education, training, and relevant work experience may be considered.

Knowledge, Skills, and Abilities:

• Good understanding of basic analytical instrumentation and qualitative and quantitative chemical analysis.
• Awareness of pharmaceutical industry quality and regulatory requirements.
• Strong problem-solving skills and a logical approach to scientific challenges.
• Ability to follow company policies, SOPs, cGMPs, work instructions, analytical methods, and laboratory guidelines.
• Ability to multitask, prioritize work, and manage time effectively to meet testing deadlines.
• Demonstrates initiative in pursuing training and learning opportunities and sharing knowledge with team members.
• Strong verbal and written communication skills.
• Ability to apply mathematical concepts to test reliability, analysis of variance, correlation, and related analytical tasks.
• Ability to work effectively in a fast-paced laboratory environment.

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