Overview
Analytical QA Associate II -DPI Jobs in Hauppauge, USA at CIPLA LTD
Job Title:
QA Associate II AQA
FLSA Classification:
Professional, Exempt
Work Location:
Happauge, NY
Work Hours:
General: 8:30AM – 5:00PM (may vary based on business needs)
Reports To:
Quality Assurance Supervisor
Salary Range: $86,000 – $95,000
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 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.
The job duties for this position include but are not limited to the following:
* Reviewing and confirming the compliance related to raw materials, in process 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:
* General shift but must be willing and able to work any assigned first or second shift. Work schedule may be Monday to Friday, Tuesday to Saturday, or…
Title: Analytical QA Associate II -DPI
Company: CIPLA LTD
Location: Hauppauge, USA
Category:
