Position Description: Quality Assurance Associate
Exciting opportunity for an experienced Quality Assurance (QA) Associate to join the QA Department at Adaptive Phage Therapeutics, Inc (APT). In this position, the candidate will guide personnel involved in GMP operations pertaining to cGMP compliance, internal procedures, regulatory requirements, and industry best practices.
- Interface with functional groups, such as Manufacturing and Quality Control (QC) to determine events (errors, deficiencies, discrepancies, deviations, and other observations) and report to management.
- Review batch production records and related production documentation, ensuring resolution of all identified issues prior product disposition. Work with internal functions to address all identified issues in a timely manner. Reports errors, deficiencies, discrepancies, and observations to management.
- Oversee revision, development and tracking of controlled documents
- Initiate and participate in standard operating procedure (SOP) revisions to improve compliance.
- Create and revise SOPs, batch records, CAPAs, deviations QA on the floor activities
- Assist with distributing tracking numbers for the quality systems
- Manage databases used for tracking of GMP/GDP documentation
- Performs QA On-the-Floor activities supporting projects, including room release, auditing critical processes, reviewing documentation in real time, and resolving issues that occur during manufacturing.
- Perform audits of manufacturing and support areas, including in-process batch record review for adherence to internal procedures and industry best practices.
- Review and dispositions executed batch records and supporting documentation for completeness, accuracy, and compliance.
- Act as first responder for on the floor quality issues in a timely manner, documentation of all events/investigations and required immediate corrective actions.
- Works with supervisory staff and department leads in meeting project deliverables in a compliant and efficient manner
- A Bachelor’s Degree in Science, Engineering, or a related technical discipline.
- 2+ years’ experience within the biologic, biopharmaceutical, or regulated pharmaceutical industry
- 1+ years’ experience in Quality Assurance/Quality Control function
- Experience with electronic batch records or LIMS
- Familiarity with Good Manufacturing Practices (GMPs) and a working knowledge of cGMP regulations
- Prior experience and ability to work in an aseptic processing environment.
- Experience working in an early phase pharmaceutical manufacturing facility highly desired
- Strong interpersonal and attention to detail skills
- Experience working with all Microsoft Office products (Teams, Excel, Word)
Compensation: Salary is industry-standard and is commensurate with experience.
To apply: Please email cover letter and resume to [email protected]
Job ID: 21.005