Cipla USA
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Analytical QA Associate II
role at
Cipla USA
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 InvaGen 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 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 some combination based on business needs.
Must be willing to work some weekends based on business needs as required by management.
Relocation negotiable.
No remote work available.
This role works in a cGMP laboratory or manufacturing environment, where personal protective equipment (PPE) such as lab coats, safety glasses, respirators, and hearing protection may be required.
Weekend or holiday work may be requested or required based on business needs.
Global Company
Cipla is a leading global pharmaceutical company dedicated to high‑quality, branded and generic medicines. It operates in key markets across India, South Africa, the U.S., and other emerging economies.
Cipla’s subsidiary, InvaGen Pharmaceuticals, Inc., develops, manufactures, markets, and distributes generic prescription medicines focusing on cardiovascular, anti‑infective, CNS, anti‑inflammatory, anti‑diabetic, and anti‑depressant therapeutic areas. It is based in Central Islip and Hauppauge, New York.
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Analytical QA Associate II
role at
Cipla USA
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 InvaGen 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 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 some combination based on business needs.
Must be willing to work some weekends based on business needs as required by management.
Relocation negotiable.
No remote work available.
This role works in a cGMP laboratory or manufacturing environment, where personal protective equipment (PPE) such as lab coats, safety glasses, respirators, and hearing protection may be required.
Weekend or holiday work may be requested or required based on business needs.
Global Company
Cipla is a leading global pharmaceutical company dedicated to high‑quality, branded and generic medicines. It operates in key markets across India, South Africa, the U.S., and other emerging economies.
Cipla’s subsidiary, InvaGen Pharmaceuticals, Inc., develops, manufactures, markets, and distributes generic prescription medicines focusing on cardiovascular, anti‑infective, CNS, anti‑inflammatory, anti‑diabetic, and anti‑depressant therapeutic areas. It is based in Central Islip and Hauppauge, New York.
#J-18808-Ljbffr