Quality Assurance Specialist
Quality Assurance Associate
Summary & Scope of Position:
The Quality Specialist will be responsible for the design, development, implementation and maintenance of the GxP QMS processes. This includes, but is not limited to, Document Control, Change Control, Deviation and other Non-conformances, CAPA, Equipment/Instrument associated systems, and Supplier Management. The role is focused on implementing and maintaining the Quality Systems associated with the manufacture of our vaccines and preparing for future clinical trials.
- Support the development, and implementation of Quality Systems
- Performs QA document control function, including document login, tracking, processing, approval, distributing, and archiving and has overall responsibility for document control processes.
- Work closely with functional areas for daily management of routing, revisions, approval, and filing of documents.
- Organizes and ensures accurate and reliable filing systems for all electronic and paper-based GMP documents.
- Maintains in house training programs including training matrix, training files, and audits of training files.
- Help implement Change Control, Supplier Management and CAPA processes
- Support domestic and international Quality System audits (e.g., CMO Qualification, Assessment, For Cause, and/or Periodic audits) to ensure that the sites operate in compliance with EU/FDA/ICH and other regulatory bodies as may be required and remain GMP inspection ready at all times.
- Support with the review of Operating Procedures (SOPs) required for supporting system change/enhancement to ensure compliance with Good Manufacturing Practices (GMPs) requirements
- Provides QA support for batch record review as needed.
Desired Skills and Experience
- BA/BS degree in scientific or engineering discipline
- Accredited quality auditor is desirable
- Four (4) to six (6) plus-years in biotech/pharma industry experience
- Must have experience in implementing quality systems and writing SOP's
- Experience with managing key Quality Management System processes (e.g., Change Management, Supplier Management, Deviations/CAPA, Management Review)
- Understanding of current regulatory expectations
- Demonstrated ability to collaborate and influence across organization to gain support and commitment for team goals; effective management of groups of professionals to achieve desired results
- Strong professional interpersonal and communications skills, both verbal and written to provide clear direction for the business, vendors, internal stakeholders
- Ability to meet deadlines and multi-task efficiently
- Proficient with the Microsoft Office Suite, Word, Excel, PowerPoint and Project