QA Analyst

Job Title
: QA Analyst II

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
: $74,984 - $96,408

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:

• 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.
• Confirming and ensuring compliance of the protocols and reports of method validations / verifications / comparison reports and any other study reports.
• Prepare and review laboratory investigation (OOS/OOT/Deviation) reports and ensure compliance.
• Verifying the laboratory chemicals/reagents, standards for completeness of the labels against standard operating procedures (SOPs).
• Assessing and implementing Pharmacopoeia changes whenever any new edition, supplement, amendment, or other changes of any Pharmacopoeia are in effect.
• Review of laboratory audit trials during data review against SOPs.
• Coordinating with the Analytical Laboratory Teams to arrange required documents to cross functional teams.
• Maintaining all the incoming documents with proper tracking, recording, storage and archival of the documents.
• Reviewing and identifying gaps within the system during routine monitoring and informing the 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 the manager/supervisor.

• Minimum bachelor's degree in chemistry, Pharmaceutical Sciences, or related field of study from an accredited institution. Master’s degree in the above and/or related fields of study is preferred.
• Minimum of 4-8 years in analytical experience, preferably in analytical quality assurance for a minimum of 3 years.
• Proficient in computer skills and software applications such as Microsoft Office tools and quality application and software programs.
• Strong knowledge and experience with analytical laboratory activities in areas such as active pharmaceutical ingredients (API), drug products, analytical development, Quality Control (QC), Good Laboratory Practices (GLP)/Good Manufacturing Practices (GMP)/Good documentation Practices (GDP), USP monograph requirements.

• Understanding of laboratory equipment operation, qualification and calibrations including software audit trial reviews (e.g., HPLC, UV Vis Spectrophotometer, GC, Potentiometer, pH meter, Stability chambers).
• Strong knowledge of USP monograph requirements, FDA & ICH guidance requirements, etc.
• Effective interpersonal relationship skills and the ability to work in a team environment.
• Experience in inhalation products (MDI/DPI) is a plus.
• Ability to work in a fast‑paced, dynamic environment within a manufacturing operation setting.
• Clear verbal, written, and interpersonal communication skills in English.
• Strong documentation and technical writing skills, and ability to apply relevant scientific principles and practices.
• Work under minimal supervision and able to work independently and in a team environment.

• Proficiently speak English as a first or second language and able to read, write and communicate effectively.
• Self‑starter and demonstrate initiative to seek additional training or direction as needed.
• Willing and able to work any assigned shift ranging from first or second shift; 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 attention to detail.

• Gene…