Quality Information Systems Specialist
Exciting opportunity for experienced Information Systems Specialist to join a clinical-stage biotech company developing innovative bacteriophage therapies addressing the global crisis of antibiotic-resistant bacterial infections.
The Quality Information Systems Specialist will participate in the design, qualification, and maintenance of information systems relevant to the manufacture of investigational product under current Good Manufacturing Practices (cGMP). The Specialist will work collaboratively across internal functions including Manufacturing, Analytical/Process Development, Quality Control, Regulatory Affairs, and Supply Chain to implement and maintain compliant electronic systems to optimize efficiency and effectiveness of cGMP operations. Takes the lead in the design of budget-conscious and phase-appropriate systems including implementation and continuous improvement to ensure appropriate, user-friendly access to information while maintaining cGMP compliant data integrity. Acts as a point of contact (POC) on Quality information systems matters, internally and externally.
- Designs, qualifies, and maintains information systems for management of Quality-related data including, but not limited to, electronic document management, electronic deviation/CAPA/investigation management, and tracking of lot file review and test results for product disposition. Includes the establishment of tools for trending performance metrics associated with batch disposition.
- Oversees the qualification and maintenance of third-party electronic systems used for cGMP applications. Includes being the Quality department lead in identifying and selecting potential new systems.
- Oversees the qualification of software used for control of equipment and instrumentation in manufacturing and quality control laboratories.
- Oversees the qualification and control of Excel spreadsheets used for cGMP operations.
- Write technical documents such as protocols, reports, change controls, and SOPs. Includes reviewing and approving these document types.
- Communicate and participate effectively and cross-functionally.
- Participate in audits as needed (internal, regulatory, and/or partner).
- Skilled in design, qualification, and deployment of electronic systems in a cGMP regulated environment.
- Expert level computer literacy, including Microsoft (MS Word, MS Excel, MS Access, SharePoint) and Adobe.
- Prior experience with InstantGMP™ a plus.
- Experience in design and implementation of cGMP compliant database tools.
- Ability to solve complex technical issues and drive to closure.
- Skill in building and maintaining cross functional relationships across areas.
- Ability to manage multiple priorities with a sense of urgency to meet timelines.
- Adaptable to change.
- Excellent communication skills; verbal and written; with various levels of internal and external organizations.
- Bachelor’s degree / equivalent in computer systems, life sciences, or related field
- 5+ years of experience in the pharmaceutical and biotechnology industries
- Strong knowledge of FDA and ex-US regulations related to computerized systems, data integrity, and 21 CFR Part 11
Compensation: Salary is industry-standard and is commensurate with experience.
To apply: Please email cover letter and resume to HR@aphage.com