QA Analyst

Job Title
: QA Analyst I (AQA)

FLSA Classification
:
Professional, Exempt

Work Location
:
Fall River, MA

Work Hours
:
General: 8:30 AM - 5:00 PM (may vary based on business needs)

Reports To
:
Quality Assurance Manager

Salary Range
: $62,400 - $75,400 (DOE)

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:

The Analytical Quality Assurance (AQA) Associate I position is a team contributor role and reports to the Supervisor Analytical Quality Assurance for Inva Gen Pharmaceuticals, Inc., a Cipla subsidiary located at Fall River, MA.

• Reviewing and confirming compliance related to raw materials, in-process, and finished product analytical documents.
• Monitoring and ensuring current Good Laboratory Practices (cGLP) are followed by laboratory personnel during routine operations to ensure adherence to procedure.
• Verifying laboratory chemicals/reagents, standards for completeness of the labels against SOPs.
• Reviewing laboratory audit trials during data review against SOPs.
• Coordinating with Analytical Laboratory Teams to arrange required documents for cross‑functional teams.
• Maintaining incoming documents with proper tracking, recording, storage, and archival.
• Reviewing and identifying gaps within the system during routine monitoring and informing supervisor of necessary improvements.
• Actively participating in review of data related to laboratory investigations and incidents and ensuring proper compliance.
• Performing other departmental and cross‑functional projects and assignments given by manager/supervisor.

• Minimum bachelor's degree in chemistry, pharmaceutical sciences, or related field from an accredited institution. Master’s degree preferred.
• 1‑3 years of experience in analytical quality assurance (preferably).
• Proficiency in computer skills and software applications such as Microsoft Office and quality applications.

• Knowledge and experience with analytical laboratory activities in areas such as active pharmaceutical ingredients (API), drug products, analytical development, QC, GLP/GMP/GDP, etc.

• Understanding of laboratory equipment operation, qualification, and calibration, including software audit trial reviews (e.g., pH meter, conductivity meter, analytical balance, UV‑Vis spectrophotometer, IR spectrophotometer).
• Effective interpersonal relationships and ability to work in a team environment.
• Experience with inhalation products (MDI) is a plus.
• Ability to work in a fast‑paced, dynamic manufacturing operation setting.
• Strong communication skills across all levels; solid command of English verbal, written, and interpersonal communication.
• Strong documentation and technical writing skills; ability to apply relevant scientific principles and practices.
• Ability to work under minimal supervision and independently.

• Proficient English speaker, ability to read, write, and communicate effectively.
• Self‑starter with initiative to seek training or direction as needed.
• Willing and able to work any assigned shift (first or second) with flexible schedules, including Monday‑Friday, Tuesday‑Saturday, or combinations based on business needs.
• Willing to work some weekends as required by management.
• Relocation negotiable; no remote work available.
• Experience in cGMP laboratory or manufacturing environment; PPE required.
• Knowledge of GMP and GDP preferred.
• Self‑motivated, fast‑paced, strong organizational skills, attention to detail.

• General shift but must be willing and able to work any assigned first or second shift; schedule may be Monday‑Friday, Tuesday‑Saturday, or combination based on business needs.
• Must be willing to work some weekends as required by management.
• Relocation negotiable; no remote work available.
• Role works in cGMP lab or manufacturing environment; PPE required (uniforms, lab coats, safety glasses, respiratory protective equipment, hearing protection).
• Role may be assigned on a work‑shift basis (Day, Evening, Night); weekend or holiday work…