Scientist II Pharmaceutical Analyst

Scientist II Pharmaceutical Analyst page is loaded## Scientist II Pharmaceutical Analyst locations: MA-Mansfield-West Building time type:
Full time posted on:
Posted Todayjob requisition :
*** What Chemistry Services Center contributes to Cardinal Health
*** Chemistry Services Center perform laboratory testing to characterize the chemistries of our medical device products and stability testing for pharmaceutical products of Cardinal Health. Chemistry Services is a part of Quality, Regulatory & Medical Affairs (QRMA) Scientific Services. Under the umbrella of QRMA, Chemistry Services Center will use specialized instruments to perform Assay and impurity/degradant tests for stability program for solid dose pharmaceuticals.
*** This role is 100% onsite at our state-of-the-art Scientific Service Center in Mansfield, MA.
****** Responsibilities
* *** As an experienced analytical chemist in Pharmaceutical Analysis Department, produces high quality data for pharmaceutical stability analyses.
* Perform data compilation, review, evaluation and trend analysis on data as applicable.
* Perform analytical testing on stability samples using various techniques like HPLC, GC, UV-Vis, Karl Fisher and dissolution testing to assess drug product stability.
* Ensure accuracy and precision of analytical methods by adhering to established quality control procedures.
* Ensure all stability testing is conducted according to cGMP principles.
* Perform analytical method verification, validation and analytical method transfer protocols following the regulatory requirements (ICH, USP and FDA).
* Perform investigations of Out of Specification (OOS) test results as needed follow FDA guidelines.
* Maintain compliance with relevant regulatory requirements (e.g. ICH and FDA) related to stability studies and data documentation.
* Communicate stability data findings to stakeholders through reports.
*** Qualifications
* *** Bachelor’s degree in chemistry or a related scientific field, preferred or equivalent work experience.
* 2-4 years of analytical laboratory experience performing analyses using HPLC, GC, UV-Vis, Karl Fisher and dissolution testing to support pharmaceutical stability testing, preferred
* Experience with commercial stability programs following ICH guidelines, preferred
* Experience with analytical method verification and validation following regulatory guidelines, preferred
* Experience with analytical method transfer following regulatory requirements such as USP , preferred
* Experience with investigations of Out of Specification (OOS) per FDA guidelines, preferred
* Knowledge of cGMP regulation/guidance.
* Experience with pharmaceutical stability test analysis software and LIMS systems for data management, preferred
* Experience with quality management systems (e.g., Track Wise, Veeva or Agile), experience with LIMS (e.g., Lab Ware) is a plus.
* Proficient in the use of instrumental data systems, including data acquisition, analysis and processing (e.g., Waters’ Empower software and Mettler Toledo’s Labx) , preferred
* Must be able to convey recommendations, data, observations, results, and problems accurately and effectively to co-workers, customers and management.
* Ability to handle multiple projects, adhere to scheduled timelines while maintaining flexibility and attention to detail.
* Good communication and interpersonal skills.

Can operate independently with minimal guidance and supervision and a team player.
*** What is expected of you and others at this level
**** Produces high quality data and provides are able to provide interpretations of pharmaceutical stability analyses.
* Experience with data chromatography acquisition software such as Waters Empower desired.
* Experience with Quality Management Software (QMS), such as Trackwise, Veeva or Agile and Laboratory Information Management System (LIMS), such as Lab Ware.
* Reports test data in a form and format that facilitates the use of the data by team members.
* Work with lab manager and senior staff members of pharmaceutical analysis department, develops instrument testing protocol and methods, standard operating procedures (SOPs), work instructions and other instrument…