QA Analyst II

CIPLA • Fall River, MA

85d • $74,984 - $96,408 • Remote

About The Position

The Analytical Quality Assurance (AQA) associate II O III position is a team or individual contributor role and reports to the Supervisor Analytical Quality Assurance for InvaGen Pharmaceuticals, Inc., a Cipla subsidiary located at Fall River, MA. This position requires a strong analytical chemistry/lab background and experience. The job duties for this position include but are not limited to reviewing and confirming the compliance related to raw materials, in-process and finished product analytical documents, monitoring and ensuring current Good Laboratory Practices (cGLP) followed by laboratory personnel during routine operation, and confirming compliance of protocols and reports of method validations/ verifications/comparison reports and any other study reports. The role also involves preparing and reviewing laboratory investigation reports, verifying laboratory chemicals/reagents, assessing and implementing Pharmacopoeia changes, reviewing laboratory audit trials, coordinating with Analytical Laboratory Teams, maintaining incoming documents, identifying gaps within the system, participating in data review related to laboratory investigations, and performing other departmental and cross-functional projects as assigned.

Requirements

• Minimum bachelor's degree in chemistry, Pharmaceutical Sciences, or related field.
• 4-8 years of experience in analytical, with at least 3 years in analytical quality assurance.
• Proficient in Microsoft Office tools and Quality applications.
• Strong knowledge and experience with analytical laboratory activities.
• Understanding of laboratory equipment operation, qualification, and calibrations.
• Effective interpersonal relationship skills and ability to work in a team environment.
• Ability to communicate clearly and concisely across all levels of the organization.
• Strong documentation and technical writing skills.

Nice To Haves

• Master's degree in chemistry, Pharmaceutical Sciences, or related field.
• Experience in Inhalation products (MDI/DPI).
• Knowledge of good manufacturing practices and good documentation practices.

Responsibilities

• Review and confirm compliance related to raw materials, in-process and finished product analytical documents.
• Monitor and ensure adherence to current Good Laboratory Practices (cGLP) by laboratory personnel.
• Confirm compliance of protocols and reports of method validations/verifications/comparison reports.
• Prepare and review laboratory investigation (OOS/OOT/Deviation) reports.
• Verify laboratory chemicals/reagents and standards for completeness of labels against SOPs.
• Assess and implement Pharmacopoeia changes.
• Review laboratory audit trials during data review against SOPs.
• Coordinate with Analytical Laboratory Teams to arrange required documents.
• Maintain tracking, recording, storage, and archival of incoming documents.
• Identify gaps within the system during routine monitoring and inform the supervisor.
• Participate in review of data related to laboratory investigations and incidents.
• Perform other departmental and cross-functional projects as assigned.

Benefits

• Relocation negotiable.
• No remote work available.
• Work in a cGMP laboratory or manufacturing environment.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Chemical Manufacturing
• Education Level: Bachelor's degree
• Number of Employees: 5,001-10,000 employees