AQA Associate I MDI

Job Title AQA Associate I Work Location Fall River, MA Work Hours General: 8:30 AM - 5:00 PM (may vary based on business needs) Reports To AQA Supervisor Salary Range $66,300 - $86,000 Purpose This position requires a strong analytical chemistry/lab background and experience. The job duties for this position include but are not limited to the following. Responsibilities Reviewing and confirming compliance related to raw materials, inprocess and finished product analytical documents. Monitoring and ensuring current Good Laboratory Practices (cGLP) are followed by laboratory personnel during routine operation to ensure adherence to procedure. Verifying laboratory chemicals/reagents and standards for completeness of the labels against standard operating procedures (SOPs). Reviewing laboratory audit trials during data review against standard operating procedures (SOPs). Coordinating with the Analytical Laboratory Teams to arrange required documents for cross‑functional teams. Maintaining all incoming documents with proper tracking, recording, storage and archival. Reviewing and identifying gaps within the system during routine monitoring and informing the supervisor of necessary improvements. Actively participating in the review of data related to laboratory investigations and incidents to ensure proper compliance. Performing other departmental and cross‑functional projects and assignments given by the manager/supervisor. Education and Experience Possess a minimum bachelor’s degree in chemistry, pharmaceutical sciences, or related field of study from an accredited institution. A master's degree in the same or related fields is preferred. Minimum of 1–3 years in analytical work, preferably in analytical quality assurance. Must be proficient in computer skills and software applications such as Microsoft Office tools and quality applications and software programs. Knowledge and Experience Experience with analytical laboratory activities in areas such as active pharmaceutical ingredients (API), drug products, analytical development, quality control (QC), GLP/GMP/GDP, etc. Technical Knowledge and Computer Systems Skills Understanding of laboratory equipment operation, qualification and calibrations, which includes software audit trial reviews (e.g., pH meter, conductivity meter, analytical balance, UV‑Vis spectrophotometer, IR spectrophotometer, etc.). Effective interpersonal relationship skills and the ability to work in a team environment. Experience in inhalation products (MDI) is a plus. Ability to work in a fast‑paced, dynamic manufacturing environment. Must be able to communicate clearly and concisely across all levels of the organization and possess a solid command of English language communication skills (verbal, written, interpersonally). Must possess strong documentation and technical writing skills and be able to apply relevant scientific principles and practices. Must be able to work under minimal supervision and work independently and in a team environment. Professional and Behavioral Competencies Proficiently speak English as a first or second language and ability to read, write and communicate effectively. Must be a self‑starter and demonstrate initiative to seek additional training or direction as needed. Must be willing and able to work any assigned shift (first or second) and work schedules may be Monday to Friday. Knowledge of good manufacturing practices and good documentation practices preferred. Self‑motivated, with the ability to work in a fast‑paced manufacturing environment and handle multiple tasks simultaneously. Excellent organizational skills with the ability to focus on details. Work Schedule & Position Information General shift but must be willing and able to work any assigned first or second shift. Work schedule may be Monday to Friday, Tuesday to Saturday, or some combination thereof based on business needs. Must be willing to work some weekends based on business needs as required by management. Relocation negotiable. No remote work available. This role works in a cGMP laboratory or manufacturing environment, where personal protective equipment (PPE) is required, which may include uniforms, lab coats, safety glasses, respiratory protective equipment, hearing protection, etc. The role may be assigned on a work‑shift basis where required (Day, Evening, Night). Weekend or Holiday work may be requested or required based on business needs. 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 Merck & Co.