Analytical QA Associate II

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NOTICE: The posting for local applicants only is not for those applying for a global assignment and/or for employees working outside of Cipla's U.S. Subsidiaries or Affiliates.

Job Title
: QA Associate II AQA

FLSA Classification
:
Professional, Exempt

Work Location
:
Hauppauge, NY

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

Reports To
:
Quality Assurance Manager

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:

Scope
:
The Analytical Quality Assurance (AQA) associate II and III position is an individual contributor role and reports to the Supervisor Analytical Quality Assurance for Inva Gen Pharmaceuticals, Inc., a Cipla subsidiary located at Hauppauge, NY.

Job Duties
:

• Reviewing and confirming 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 to ensure adherence to procedures.
• Confirming and ensuring compliance of protocol and report validation/verification/comparison reports and any other study reports.
• Preparing and reviewing laboratory investigation (OOS/OOT/Deviation) reports and ensuring compliance.
• Verifying laboratory chemicals/reagents, standards for completeness of labels against SOPs.
• Assessing and implementing Pharmacopoeia changes whenever a new edition, supplement, amendment, or other changes of any Pharmacopoeia are in effect.
• Reviewing laboratory audit trails during data review against SOPs.
• Coordinating with Analytical Laboratory Teams to arrange required documents to cross‑functional teams.
• Maintaining all 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 in identified areas.
• 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.

Education and Experience
:

• Minimum bachelor’s degree in chemistry, pharmaceutical sciences, or related field of study from an accredited institution. Master’s degree preferred.
• Minimum 4-8 years in analytical (preferably analytical quality assurance for minimum 3 years).
• Proficient in computer skills and software applications such as Microsoft Office tools and quality applications.
• Strong knowledge and experience with analytical laboratory activities in areas such as API, drug products, analytical development, QC, GLP/GMP/GDP, USP monograph requirements.

Technical Knowledge and Computer System Skills
:

• Understanding of laboratory equipment operation, qualification, and calibrations including software audit trail reviews (e.g., HPLC, UV‑Vis spectrophotometer, GC, potentiometer, pH meter, stability chambers).
• Strong knowledge on USP monograph requirements, FDA & ICH guidance requirements.
• Effective interpersonal relationship skills and ability to work in a team environment.
• Experience in inhalation products (DPI) is a plus.
• Ability to work in a fast‑paced, dynamic environment within a manufacturing operation setting.
• Excellent command of English language communication skills, verbally, written, and interpersonally.
• Strong documentation and technical writing skills, and ability 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
:

• Proficient speaking English as a first or second language.
• Self‑starter with 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 ability to work in a fast‑paced manufacturing…