Analytical Quality Assurance Associate I
- Fall River, MA
- Permanent
- Full-time
Responsibilities
- 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.
- 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.
- 1-3 years of analytical experience (preferably in analytical quality assurance).
- 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.
- 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.
- Experience in Inhalation products (DPI) is a plus.
- Ability to work in a fast-paced, dynamic environment within a manufacturing operation setting.
- Knowledge of good manufacturing practices and good documentation practices preferred.
- 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.
- Effective interpersonal relationship skills and the ability to work in a team environment.