YO IT Group
Mandatory 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. Experience with inhalation products (DPI) is a plus. Purpose and Scope
This position requires a strong analytical chemistry/lab background. The Analytical Quality Assurance (AQA) Associate II/III is an individual contributor role (or part of a team) reporting to the Supervisor, Analytical Quality Assurance. Key Responsibilities
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. Skills: quality assurance,api,active pharmaceutical ingredients,chemistry,analitical,equipment operation
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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. Experience with inhalation products (DPI) is a plus. Purpose and Scope
This position requires a strong analytical chemistry/lab background. The Analytical Quality Assurance (AQA) Associate II/III is an individual contributor role (or part of a team) reporting to the Supervisor, Analytical Quality Assurance. Key Responsibilities
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. Skills: quality assurance,api,active pharmaceutical ingredients,chemistry,analitical,equipment operation
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