What are the responsibilities and job description for the QC Data Reviewer position at Exela Pharma Sciences?
Position Summary
The Technical Data Reviewer reports to the Data Review Supervisor or quality management (i.e., Manager or Director). The reviewer will be responsible for the review of logbooks for daily, monthly, quarterly, and final reviews, as well as reviewing and approving data associated with Raw Material, Finished Drug Products, Stability and Microbiology testing. Data Review may include release, raw material, and stability data and laboratory notebooks. Additionally, the reviewer will need to ensure that all activities are performed in compliance with cGDP, cGLP and cGMP requirements.
Job Responsibilities
- Review logbooks for daily, monthly, quarterly, and final Quality Review.
- Review and approve Particle Matter, Helium Leak, Physical Testing and HPLC data of incoming Raw Materials, Finished Drug Products and Stability studies.
- Review data transcription in LIMS.
- Review and ensure all activities are performed in compliance with cGDP, cGLP and cGMP requirements.
- Other duties as assigned.
- Remain current with departmental procedures, corporate policies and the regulatory requirements of the U.S Food and Drug Administration.
Experience Requirements
- Knowledge and experience with FDA regulations.
- Self-motivated with demonstrated ability to work effectively with people from multiple departments, ensure deadlines are met, and manage multiple and changing priorities.
- Excellent communication, collaboration, teamwork, and interpersonal skills.
- Superb ability to effectively communicate with staff members and business partners at all levels of the organization (both internal and external).
- Must be able to read and write English, perform mathematical calculations, follow instructions, attend to details, multi-task, and handle multiple priorities without undue stress or errors.
Education Requirements
- A Bachelor’s Degree in Biology or Chemistry or related scientific discipline with approximately 3 – 5 years of Analytical Chemistry or Microbiology experience required; preferably in QC, in the pharmaceutical industry.
- Other combinations of related education and/or experience may be accepted in lieu of education and working experience in the pharmaceutical industry.
