Job Description
Job Description
Job Description
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.
Job Tags
Work at office, Shift work, Afternoon shift, Monday to Friday,