QA Analytical – Pharma

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.

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.

• 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.

• 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.

• 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.

• 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:

chemistry,quality assurance,api,equipment operation,active pharmaceutical ingredients,analitical