Quality Assurance Analyst I

Cipla • Fall River, MA

11d • Onsite

About The Position

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 an team contributor role and reports to the Supervisor Analytical Quality Assurance for InvaGen Pharmaceuticals, Inc., a Cipla subsidiary located at Fall River, MA. 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. Verifying the laboratory chemicals/reagents, standards for completeness of the labels against standard operating procedures (SOPs). 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.

Requirements

• Possess a minimum bachelor’s degree in chemistry, Pharmaceutical Sciences, or related field of study from an accredited institution.
• A minimum of 1-3 years in analytical (preferably in analytical quality assurance).
• Must be proficient in computer skills and software applications such as Microsoft Office tools and Quality applications and software programs.
• 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), etc.
• Understanding of laboratory equipment operation, qualification and calibrations which includes their software audit trial reviews. E.g. pH meter, conductivity meter, analytical balance, UV-Vis spectrophotometer, IR Spectrophotometer, etc.
• Effective interpersonal relationship skills and the ability to work in a team environment.
• 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.
• 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.
• 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.

Nice To Haves

• Master’s degree in the above and/or related fields of study as noted above preferred.
• Experience in Inhalation products (MDI) is a plus.
• Knowledge of good manufacturing practices and good documentation practices preferred.

Responsibilities

• 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.
• Verifying the laboratory chemicals/reagents, standards for completeness of the labels against standard operating procedures (SOPs).
• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Number of Employees: 5,001-10,000 employees