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.

Job Title:

QA Associate II AQA

FLSA Classification:
Professional, Exempt

Work Location:

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

The job duties for this position include but are not limited to the following:

* Reviewing and confirming the compliance related to raw materials, inprocess and finished product analytical documents.

* Monitoring and ensuring of current Good Laboratory Practices (cGLP) 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 of same.

* 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 standard operating procedures (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 the gaps within the system during routine monitoring and informing the supervisor of necessary improvements in the 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

* Possess a 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 as noted above preferred.

* A minimum of 4-8 years in analytical (preferably in analytical quality assurance for minimum 3years).

* Must be proficient in computer skills and software applications such as Microsoft Office tools and Quality applications 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,.

Technical Knowledge and Computer Systems Skills

* Understanding of laboratory equipment operation, qualification and calibrations which includes their 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, etc.

* Effective interpersonal relationship skills and the 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.

* Must be able to communicate clearly and concisely across all levels of the organization and possess a solid command of English language communication skills verbally, written, and interpersonally.

* Must possess strong documentation and technical writing skills, and able to apply relevant scientific principles and practices.

* Must be able to work under minimal supervision and able to work independently and in a team environment.

Professional and Behavioral Competencies

* Proficiently speak English as a first or second language and ability to read, write and communicate effectively the same.

* Must be a self-starter and demonstrate initiative to seek additional training or direction as needed.

* Must be 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 the ability to focus on details.

Work Schedule and Other Position Information:

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