Cipla USA
Job Title : QA Analyst I (AQA)
FLSA Classification : Professional, Exempt
Work Location : Fall River, MA
Work Hours : General: 8:30 AM - 5:00 PM (may vary based on business needs)
Reports To : Quality Assurance Manager
Salary Range : $62,400 - $75,400 (DOE)
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 I position is a team contributor role and reports to the Supervisor Analytical Quality Assurance for InvaGen Pharmaceuticals, Inc., a Cipla subsidiary located at Fall River, MA.
Responsibilities
Reviewing and confirming compliance related to raw materials, in-process, and finished product analytical documents.
Monitoring and ensuring current Good Laboratory Practices (cGLP) are followed by laboratory personnel during routine operations to ensure adherence to procedure.
Verifying laboratory chemicals/reagents, standards for completeness of the labels against SOPs.
Reviewing laboratory audit trials during data review against SOPs.
Coordinating with Analytical Laboratory Teams to arrange required documents for cross‑functional teams.
Maintaining incoming documents with proper tracking, recording, storage, and archival.
Reviewing and identifying gaps within the system during routine monitoring and informing 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 manager/supervisor.
Education and Experience
Minimum bachelor's degree in chemistry, pharmaceutical sciences, or related field from an accredited institution. Master’s degree preferred.
1‑3 years of experience in analytical quality assurance (preferably).
Proficiency in computer skills and software applications such as Microsoft Office and quality applications.
Knowledge and experience with analytical laboratory activities in areas such as active pharmaceutical ingredients (API), drug products, analytical development, QC, GLP/GMP/GDP, etc.
Technical Knowledge and Computer Systems Skills
Understanding of laboratory equipment operation, qualification, and calibration, including software audit trial reviews (e.g., pH meter, conductivity meter, analytical balance, UV‑Vis spectrophotometer, IR spectrophotometer).
Effective interpersonal relationships and ability to work in a team environment.
Experience with inhalation products (MDI) is a plus.
Ability to work in a fast‑paced, dynamic manufacturing operation setting.
Strong communication skills across all levels; solid command of English verbal, written, and interpersonal communication.
Strong documentation and technical writing skills; ability to apply relevant scientific principles and practices.
Ability to work under minimal supervision and independently.
Professional and Behavioral Competencies
Proficient English speaker, ability to read, write, and communicate effectively.
Self‑starter with initiative to seek training or direction as needed.
Willing and able to work any assigned shift (first or second) with flexible schedules, including Monday‑Friday, Tuesday‑Saturday, or combinations based on business needs.
Willing to work some weekends as required by management.
Relocation negotiable; no remote work available.
Experience in cGMP laboratory or manufacturing environment; PPE required.
Knowledge of GMP and GDP preferred.
Self‑motivated, fast‑paced, strong organizational skills, attention to detail.
Work Schedule and Other Position Information
General shift but must be willing and able to work any assigned first or second shift; schedule may be Monday‑Friday, Tuesday‑Saturday, or combination based on business needs.
Must be willing to work some weekends as required by management.
Relocation negotiable; no remote work available.
Role works in cGMP lab or manufacturing environment; PPE required (uniforms, lab coats, safety glasses, respiratory protective equipment, hearing protection).
Role may be assigned on a work‑shift basis (Day, Evening, Night); weekend or holiday work may be requested or required.
GLOBAL COMPANY Cipla is a leading global pharmaceutical company, dedicated to high‑quality, branded and generic medicines. We are trusted by healthcare professionals and patients across geographies. With eight decades of leadership, we have strengthened our presence in India, South Africa, the U.S., and other emerging markets.
Cipla employs handpicked professionals not just for their knowledge and experience but for their zeal to make a difference in healthcare. The company believes that our biggest assets are our employees who lead us to prosperity and growth. Driven by vision, we focus on making affordable, world‑class medicines with uncompromising quality standards.
Equal Opportunity Employer Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status. At Cipla, we welcome people of all abilities and want to ensure our hiring and interview process meets the needs of all applicants. If you require reasonable accommodation, please contact the recruiter.
Salary Details The salary range mentioned above is an anticipated base salary range for this position. Exact salary depends on experience, skills, education, and budget. Salary may vary by location. In addition to base salary, this position may be eligible for benefits and participation in a bonus program based on performance and company results.
#J-18808-Ljbffr
FLSA Classification : Professional, Exempt
Work Location : Fall River, MA
Work Hours : General: 8:30 AM - 5:00 PM (may vary based on business needs)
Reports To : Quality Assurance Manager
Salary Range : $62,400 - $75,400 (DOE)
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 I position is a team contributor role and reports to the Supervisor Analytical Quality Assurance for InvaGen Pharmaceuticals, Inc., a Cipla subsidiary located at Fall River, MA.
Responsibilities
Reviewing and confirming compliance related to raw materials, in-process, and finished product analytical documents.
Monitoring and ensuring current Good Laboratory Practices (cGLP) are followed by laboratory personnel during routine operations to ensure adherence to procedure.
Verifying laboratory chemicals/reagents, standards for completeness of the labels against SOPs.
Reviewing laboratory audit trials during data review against SOPs.
Coordinating with Analytical Laboratory Teams to arrange required documents for cross‑functional teams.
Maintaining incoming documents with proper tracking, recording, storage, and archival.
Reviewing and identifying gaps within the system during routine monitoring and informing 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 manager/supervisor.
Education and Experience
Minimum bachelor's degree in chemistry, pharmaceutical sciences, or related field from an accredited institution. Master’s degree preferred.
1‑3 years of experience in analytical quality assurance (preferably).
Proficiency in computer skills and software applications such as Microsoft Office and quality applications.
Knowledge and experience with analytical laboratory activities in areas such as active pharmaceutical ingredients (API), drug products, analytical development, QC, GLP/GMP/GDP, etc.
Technical Knowledge and Computer Systems Skills
Understanding of laboratory equipment operation, qualification, and calibration, including software audit trial reviews (e.g., pH meter, conductivity meter, analytical balance, UV‑Vis spectrophotometer, IR spectrophotometer).
Effective interpersonal relationships and ability to work in a team environment.
Experience with inhalation products (MDI) is a plus.
Ability to work in a fast‑paced, dynamic manufacturing operation setting.
Strong communication skills across all levels; solid command of English verbal, written, and interpersonal communication.
Strong documentation and technical writing skills; ability to apply relevant scientific principles and practices.
Ability to work under minimal supervision and independently.
Professional and Behavioral Competencies
Proficient English speaker, ability to read, write, and communicate effectively.
Self‑starter with initiative to seek training or direction as needed.
Willing and able to work any assigned shift (first or second) with flexible schedules, including Monday‑Friday, Tuesday‑Saturday, or combinations based on business needs.
Willing to work some weekends as required by management.
Relocation negotiable; no remote work available.
Experience in cGMP laboratory or manufacturing environment; PPE required.
Knowledge of GMP and GDP preferred.
Self‑motivated, fast‑paced, strong organizational skills, attention to detail.
Work Schedule and Other Position Information
General shift but must be willing and able to work any assigned first or second shift; schedule may be Monday‑Friday, Tuesday‑Saturday, or combination based on business needs.
Must be willing to work some weekends as required by management.
Relocation negotiable; no remote work available.
Role works in cGMP lab or manufacturing environment; PPE required (uniforms, lab coats, safety glasses, respiratory protective equipment, hearing protection).
Role may be assigned on a work‑shift basis (Day, Evening, Night); weekend or holiday work may be requested or required.
GLOBAL COMPANY Cipla is a leading global pharmaceutical company, dedicated to high‑quality, branded and generic medicines. We are trusted by healthcare professionals and patients across geographies. With eight decades of leadership, we have strengthened our presence in India, South Africa, the U.S., and other emerging markets.
Cipla employs handpicked professionals not just for their knowledge and experience but for their zeal to make a difference in healthcare. The company believes that our biggest assets are our employees who lead us to prosperity and growth. Driven by vision, we focus on making affordable, world‑class medicines with uncompromising quality standards.
Equal Opportunity Employer Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status. At Cipla, we welcome people of all abilities and want to ensure our hiring and interview process meets the needs of all applicants. If you require reasonable accommodation, please contact the recruiter.
Salary Details The salary range mentioned above is an anticipated base salary range for this position. Exact salary depends on experience, skills, education, and budget. Salary may vary by location. In addition to base salary, this position may be eligible for benefits and participation in a bonus program based on performance and company results.
#J-18808-Ljbffr