Exciting opportunity for experienced analytical leader to join Adaptive Phage Therapeutics, Inc. (APT), a clinical-stage biotech company developing innovative bacteriophage therapies addressing the global crisis of antibiotic-resistant bacterial infections.
The QA Specialist/Sr. Specialist will participate in the day-to-day operations of QA. The QA Specialist/Sr. Specialist will work collaboratively across internal functions including Manufacturing, Analytical/Process Development, Quality Control, Regulatory Affairs, and Supply Chain to ensure QA deliverables are met. Assist in the design of phase-appropriate QAD systems including implementation and continuous improvement to ensure patient safety and data integrity. Act as a point of contact (POC) on QA matters, internally and externally.
- Review and approve master and executed GMP documentation including production records, testing records, deviations, investigations, reports, protocols, change controls, SOPs and CAPAs.
- Prepare lot release documents, including certificate of analyses (CoAs) for final management approval. Ensure resolution of all identified issues prior to lot disposition (e.g. investigations, deviations).
- Act as first responder for on the floor quality issues in a timely manner, assists in the documentation of events and identifying required containment/corrective actions as appropriate.
- Assist in the tracking and reporting of lot disposition status to management and other stakeholders.
- Write technical documents such as reports, change controls, and SOPs. Includes reviewing and approving these document types.
- Ensure work is conducted following cGMP requirements and APT procedures and that QA deliverables are met.
- Communicate and participate effectively and cross-functionally.
- Participate in audits as needed (internal, regulatory, and/or partner).
- Skilled in design and deployment of QA programs and procedures.
- 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 of Science degree / equivalent in life sciences or related field.
- 5+ years of experience in the pharmaceutical and biotechnology industries.
- Strong knowledge of FDA and ex-US regulations in development through commercial.
- Fluency with regularly used Microsoft software applications (Word, Excel, PowerPoint, SharePoint).
- Experience with government contracting desired.
Compensation: Salary is industry-standard and is commensurate with experience.
To apply: Please email cover letter and resume to [email protected]
Job ID: 21.026