Nesco Resource
Analytical Quality Assurance Associate I
Nesco Resource, New Bedford, Massachusetts, United States, 02740
Analytical QA Associate I
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. Education and Experience: 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. Nesco Resource offers a comprehensive benefits package for our associates, which includes a MEC (Minimum Essential Coverage) plan that encompasses Medical, Vision, Dental, 401K, and EAP (Employee Assistance Program) services. Nesco Resource provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.
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. Education and Experience: 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. Nesco Resource offers a comprehensive benefits package for our associates, which includes a MEC (Minimum Essential Coverage) plan that encompasses Medical, Vision, Dental, 401K, and EAP (Employee Assistance Program) services. Nesco Resource provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.