50 % onsite required
Work Schedule: Mon- Fri (normal business hours)
Job Description:
The candidate will be responsible for supporting product robustness for the commercial biopharma portfolio in client and third-party manufacturing sites. Duties include supporting the Continued Process Verification program through testing and maintaining data analytics systems as well as supporting statistical process control documentation and leading/supporting cross-functional meetings.
Duties/Responsibilities:
- Provide support to maintain the product/site Statistical Process Control (SPC) program, manufacturing performance trending and reporting
- Manage and support investigations as a result of robustness events and SPC trending
- Provide system administration/maintenance of the robustness system
- Manipulate existing data files, edit information that has previously been compiled, proofread new entries within the database for accuracy
- Create forms/pages for data entry as required and data mine completed Manufacturing Batch Records
- Compile, sort and verify accuracy of data to be entered and compare data entered against source documents
Qualifications:
- Knowledge of SOPs, cGMPs and the know how to work and manage within a regulatory environment
- Excellent verbal & written communications skills. Interpersonal/facilitation skills necessary to interface with and influence all levels of the organization.
- Demonstrated ability to take initiative, prioritize objectives from multiple projects, and to adhere to scheduled timelines while maintaining flexibility
- Proven leadership skills with ability to direct and influence a team
- Knowledge of MS Word and Excel a must
- Strong technical background with knowledge of data management and ability to work with different data sources across different platforms
- Perform hands-on analysis of large volumes of data
- Easily pick up new technology
- Exceptional attention to detail
- Effective time management and project management
- Able to learn quickly working with new databases and create forms for data entry
- Experience with data analytics software is preferred
- Experience performing statistical analysis and experience using a statistical software program is preferred
- Able to coordinate review and approvals of documentation through quality systems
- Knowledge of manufacturing operations, especially biopharmaceutical manufacturing operations is preferred.
Education/Experience:
- Bachelors Degree in Chemistry, Chemical Engineering, Biomedical Science, Information Technology, or equivalent degree required.
- At least one year experience supporting a Continued Process Verification Program preferred.
