Position Summary:
This role oversees Quality Assurance activities in compliance with Good Manufacturing Practice (GMP) regulations. Responsibilities include incoming material release, batch release, change control, event management, supplier qualification, and validation compliance.
Supports various departments to ensure adherence to quality system elements, business goals, and regulatory requirements.
General Scope of Responsibilities:
Provides direction and support to all departments in regards to specific quality system elements to ensure business, quality, and compliance objectives are met.
Collaborates with other departments to efficiently implement compliance systems.
Duties:
* Batch Record Review & Material Release for GMP Compliance
* Event Management System Administration, including Event Review & Approval, Deviations, and Customer Complaints
* Batch Record Design and Approval Management
* SAP Quality Management Module Administration
* Site Change Control Systems Management
* Annual Product Reviews Compilation
* Validation Activities Support on Site, as per Site Validation Master Plan
* Validation Protocols and Reports Approval and Compilation
* System Qualification and Process Validation Activities Support
* SOPs/Work Instructions/Forms Review and Approval from Other Departments
* Regulatory and Customer GMP Inspections Preparation and Coordination
* New Product Introduction Team Participation
* GMP Audits on Site and Vendor Facilities Performance
* Floor Walkdowns for Process and Facility Maintenance
* Site Supplier Approval Process Administration
Key Skills and Competencies Required:
* Excellent Interpersonal Skills
* Able to Operate as Part of a Team
* Customer Focus
* Innovative
* Excellent Communication Skills (Written and Verbal)
* Attention to Detail
* Good Problem Solving Skills
* Results-Driven and Performance-Oriented
* Adaptable and Flexible
* Decision-Making
Qualifications and Experience:
Essential:
Quality Assurance Specialist - QA Operations
Bachelor's Degree in a Scientific/Technical Discipline Required
Minimum 3-5 Years' Experience in Quality, Validation, or Compliance Role within Biological and/or Pharmaceutical Industry
Knowledgeable of FDA/EMEA Regulatory Requirements Applicable to Biologics and/or Pharmaceuticals
Demonstrated Knowledge and Application of Industry Regulations as they Apply to Quality
Desirable:
Experience in Auditing External Suppliers, Contractors, and Vendors