BiomX is a clinical-stage biotech dedicated to advancing therapies aimed at treating multi-drug resistant infections. Our mission is to tackle today's most challenging infections and those on the horizon. We are seeking driven and insightful individuals to join us in pursuing these goals.
The QA Specialist will participate in the day-to-day operations of the Quality Assurance Department. The QA Specialist will work collaboratively across internal functions at US and Israeli sites to ensure QA deliverables are met. The QA Specialist will assist in the design of phase appropriate QAD systems including implementation and continuous improvement to ensure patient safety and data integrity, and act as a point of contact (POC) on QA matters, internally and externally.
Essential Functions
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).
Assist in the documentation of events and identifying required containment/corrective actions as appropriate.
Assist in the tracking and reporting of quality documentation and systems status to management and other stakeholders.
Write technical documents such as reports, change controls, and SOPs. Includes reviewing and approving these document types.
Assist in identification, development, and implementation of quality management systems (QMS).
Prepare and manage documents through established QMS.
Ensure work is conducted following cGxP requirements and established procedures and that QA deliverables are met.
Communicate and participate effectively and cross-functionally.
Participate in audits as needed (internal, regulatory, and/or partner).
Position Requirements
Required & Preferred Education And Experience
Bachelor of Science degree / equivalent in life sciences or related field.
5+ years of experience in the pharmaceutical and biotechnology industries.
Knowledge of FDA and ex-US Good Manufacturing Practice (GMP) regulations.
Experience with electronic quality management systems.
Competencies
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.
Strong knowledge of FDA and ex-US regulations in pharmaceutical product development through commercial launch.
Fluency with regularly used Microsoft software applications (Word, Excel, PowerPoint, SharePoint).
Other duties as needed.
About the Organization BiomX (formerly Adaptive Phage Therapeutics) is a clinical-stage biotech dedicated to advancing therapies aimed at treating multi-drug resistant infections. Our mission is to tackle today's most challenging infections and those on the horizon. We are seeking driven and insightful individuals to join us in pursuing these goals.
EOE Statement We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status or any other characteristic protected by law.
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Quality Assurance
Industries
Biotechnology
Referrals increase your chances of interviewing at Adaptive Phage Therapeutics by 2x