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. 

Responsibilities:

  • 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).

Knowledge/Skills/Abilities:

  • 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.

Education/Previous Experience:

  • 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