Quality Assurance Documentation (QAD) Specialist/ Sr. Specialist
Exciting opportunity for experienced QAD Specialist/Sr. Specialist 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 QAD Specialist/Sr. Specialist will manage the day-to-day operations of QAD. The QAD Specialist/Sr. Specialist will work collaboratively across internal functions including Manufacturing, Analytical/Process Development, Quality Assurance, Regulatory Affairs, and Supply Chain to ensure QAD deliverables are met. Assist in the design of phase-appropriate QAD systems including implementation and continuous improvement to ensure compliant and efficient management of controlled documents per current Good Manufacturing Practice (cGMP) regulations. Act as internal point of contact (POC) on QAD matters.
- Responsible for day-to-day operations of QAD, including design, deployment, and continuous improvement of the QAD systems and programs.
- Ensure QAD work is conducted following cGMP requirements and APT procedures and that QAD deliverables are met.
- Write technical documents such as reports, change controls, and SOPs.
- Manage and facilitate the system(s) for creation and revision of master GMP documents.
- Manage and facilitate the system(s) for issuance and reconciliation of controlled documents.
- Responsible for QAD archiving, retrieval, and provision of controlled documents, including hardcopy and electronic files.
- Communicate effectively and cross-functionally.
- Participate in audits as needed (internal, regulatory, and/or partner).
- Skilled in design and deployment of QAD programs and procedures.
- Expert level computer literacy, including Microsoft (Word, Excel, PowerPoint, SharePoint) and Adobe.
- 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.
- 5+ years of experience in the pharmaceutical and biotechnology industries.
- Knowledge of FDA and ex-US Good Manufacturing Practice (GMP) regulations.
- Experience with electronic QAD systems desired.
- Experience with government contracting desired.
Compensation: Salary is industry-standard and is commensurate with experience.
To apply: Please email cover letter and resume to HR@aphage.com