Quality Assurance Analyst

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)

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:

The Analytical Quality Assurance (AQA) associate I position is a team contributor role and reports to the Supervisor Analytical Quality Assurance for Inva Gen Pharmaceuticals, Inc., a Cipla subsidiary located at Fall River, MA.

• 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.

• 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 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.
• Experience in Inhalation products (MDI) 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.

• 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.

• General…