Analytical Quality Assurance
hace 13 días
New York
Job DescriptionMandatory Requirements • Minimum bachelor’s degree in Chemistry, Pharmaceutical Sciences, or a related field from an accredited institution. Master’s degree preferred., • 4–8 years of analytical experience (preferably at least 3 years in analytical quality assurance)., • Proficient in Microsoft Office and quality applications/software programs., • Strong knowledge and experience with analytical laboratory activities for APIs and drug products, including analytical development and Quality Control (QC)., • Familiarity with Good Laboratory Practices (GLP), Good Manufacturing Practices (GMP), Good Documentation Practices (GDP), and USP monograph requirements., • Understanding of laboratory equipment operation, qualification, calibration, and software audit trail review (e.g., HPLC, UV-Vis spectrophotometer, GC, potentiometer, pH meter, stability chambers)., • Knowledge of FDA and ICH guidance requirements., • Effective interpersonal skills and ability to work in a team environment., • Review and confirm compliance of analytical documents for raw materials, in-process, and finished products., • Monitor and ensure adherence to current Good Laboratory Practices (cGLP) during routine laboratory operations., • Confirm compliance of method validations, verifications, comparison reports, and other study reports., • Prepare and review laboratory investigations (OOS/OOT/Deviations) and ensure compliance., • Verify laboratory chemicals, reagents, and standards for completeness of labeling per SOPs., • Assess and implement Pharmacopoeia changes (editions, supplements, amendments) as they become effective., • Review laboratory audit trails during data review against SOPs., • Coordinate with analytical laboratory teams to provide required documents to cross-functional teams., • Maintain incoming documents with proper tracking, recording, storage, and archival., • Identify system gaps during routine monitoring and report improvement opportunities to the supervisor., • Participate in review of data related to laboratory investigations and incidents to ensure compliance., • Support departmental and cross-functional projects and assignments as directed by management.Education and Experience, • Bachelor’s degree in Chemistry, Pharmaceutical Sciences, or related field required; Master’s preferred., • 4–8 years of analytical experience, with preference for 3+ years in analytical quality assurance., • Proficiency with computer systems, Microsoft Office, and quality applications.Technical Knowledge and Computer Systems Skills, • Operation, qualification, and calibration of laboratory equipment and software audit trail review., • Experience with HPLC, UV-Vis spectrophotometer, GC, potentiometer, pH meters, stability chambers, etc., • Knowledge of USP monograph requirements, FDA, and ICH guidance., • Strong documentation and technical writing skills; ability to apply scientific principles and practices., • Ability to work independently and as part of a team in a fast-paced manufacturing environment.Professional and Behavioral Competencies, • Proficient English communication skills (verbal and written)., • Self-starter with initiative to seek training or direction as needed., • Willingness to work assigned shifts (first or second shift); schedules may be Monday to Friday., • Knowledge of good manufacturing and documentation practices preferred., • Self-motivated, organized, and able to handle multiple tasks simultaneously with attention to detail.