AQA Associate II MDI

FLSA Classification: Professional, Exempt Work Location: Fall River, MA Work Hours: General: 8:30AM – 5:00PM (may vary based on business needs) Reports To: AQA Supervisor Salary Range: $86,000 - $95,000 Purpose: This position requires a strong analytical chemistry/lab background and experience. The Analytical Quality Assurance (AQA) Associate II or III is an individual or team contributor role that reports to the AQA Supervisor at InvaGen Pharmaceuticals, Inc., a Cipla subsidiary located in Fall River, MA. Responsibilities: Confirm compliance related to raw materials, in‑process, and finished product analytical documents. Monitor and ensure adherence to good laboratory practices (cGLP) during routine operations. Ensure protocols and reports of method validations/verification, comparison reports, and other study reports are compliant. Prepare and review laboratory investigation (OOS/OOT/Deviation) reports and ensure compliance. Verify laboratory chemicals, reagents, and standards for label completeness against SOPs. Assess and implement pharmacopoeia changes whenever new editions, supplements, or amendments are in effect. Review laboratory audit trials against SOPs. Coordinate with the Analytical Laboratory Teams to arrange required documents for cross‑functional teams. Maintain incoming documents with proper tracking, recording, storage, and archival. Identify gaps during routine monitoring and inform the supervisor of necessary improvements. Participate actively in review of data related to laboratory investigations and incidents to ensure compliance. Perform departmental and cross‑functional projects and assignments as directed by the manager/supervisor. Education and Experience: Minimum bachelor’s degree in chemistry, pharmaceutical sciences, or related field; master’s degree preferred. 4–8 years of analytical experience, preferably including at least 3 years in analytical quality assurance. Proficient in Microsoft Office and quality-related software applications. Strong knowledge of analytical activities in areas such as API, drug products, analytical development, QC, GLP/GMP/GDP, and USP monograph requirements. Technical Knowledge and Computer Systems Skills: Understanding of laboratory equipment operation, qualification, and calibration including software audit trial reviews (e.g., HPLC, UV‑Vis Spectrophotometer, GC, potentiometer, pH meter, stability chambers). Knowledge of USP monograph requirements, FDA and ICH guidance. Effective interpersonal skills and ability to work in a team environment. Experience with inhalation products (MDI/DPI) is a plus. Capability to work in a fast‑paced, dynamic manufacturing setting. Clear communication across all organizational levels in English (verbal, written, interpersonal). Strong documentation and technical writing skills. Ability to work under minimal supervision and independently. Professional and Behavioral Competencies: Proficient English language skills. Self‑starter willing to seek additional training or direction as needed. Flexible to work any assigned shift (first or second), including Mondays to Fridays or other combinations as required. Knowledge of good manufacturing and documentation practices preferred. Self‑motivated and capable of handling multiple tasks simultaneously. Excellent organizational skills with a focus on detail. Work Schedule and Other Position Information: Willingness to work any assigned first or second shift; schedules may include Monday to Friday, Tuesday to Saturday, or other combinations based on business needs. Availability to work weekends as required. No remote work available. Work in a cGMP laboratory or manufacturing environment; personal protective equipment required. Weekend or holiday work may be requested or required as needed. EEO Statement: Cipla is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, age, sex, sexual orientation, gender identity, religion, national origin, genetic information, disability, or protected veteran status. #J-18808-Ljbffr Cipla