AQA QA Associate II

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.

QA Associate II AQA

Professional, Exempt

Central Islip, NY

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

Quality Assurance Manager

$86K- $95K

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 II III position is a team or individual contributor role and reports to the Supervisor Analytical Quality Assurance for Inva Gen Pharmaceuticals, Inc., a Cipla subsidiary located at Hauppauge, NY.

• 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.
• Preparing and reviewing laboratory investigation (OOS/OOT/Deviation) reports and ensuring compliance.
• Verifying 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 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.

• Possess a minimum bachelor’s degree in chemistry, Pharmaceutical Sciences, or related field from an accredited institution. Master’s degree preferred.
• Minimum of 4-8 years in analytical experience (preferably in analytical quality assurance for a minimum of 3 years).
• Proficient computer skills and software applications such as Microsoft Office and quality applications.
• 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, etc.).
• Strong knowledge on USP monograph requirements, FDA & ICH guidance requirements.
• Experience in inhalation products (DPI) is a plus.

• Strong communication skills; able to communicate clearly and concisely at all levels.
• Strong documentation and technical writing skills.
• Self‑starter, demonstrates initiative, works independently and in team.
• Can work any assigned shift ranging from first or second shift;
  Monday–Friday (with possible weekend/holiday work).
• Knowledge of good manufacturing practices and good documentation practices preferred.
• Excellent organizational skills with focus on detail.

• General shift but must be willing to work any assigned first or second shift; shift schedules may be Monday–Friday, Tuesday–Saturday, or combinations based on needs.
• Must be willing to work some weekends as required.
• Relocation negotiable.
• No remote work; must work in a cGMP laboratory or manufacturing environment with PPE.
• Work shift may be Day, Evening, or Night; weekend or holiday work may be requested.