Quality Assurance Representative

Quality Assurance Representative

The Quality Assurance Representative position is essential for ensuring GMP compliance in the design, delivery, verification, qualification, and startup phases to ensure regulatory approval of the facility. As the project progresses, this role will transition to a site-based process team supporting one of the following manufacturing areas:

• Formulation and Parenteral Manufacturing
• Device Assembly and Packaging Manufacturing
• Warehouse Logistics
• Facility, Utility, and Maintenance

Key Responsibilities:

• Demonstrate strong knowledge of cGMP practices including good documentation practices, data integrity, and regulatory compliance.
• Act as a cGMP liaison for commissioning and qualification activities, working with project teams and facility delivery groups to complete detailed design of assigned areas using QbD and QRM principles while ensuring integration of Global Quality System requirements.
• Actively participate in required design reviews and final design qualification activities by providing quality review and approval of project documentation.
• Provide quality oversight for the verification and qualification of manufacturing buildings, including review of test cases, test execution, and discrepancy resolution.
• Work with Site Quality Leadership to support the development of the vision and strategy for overall site quality operations and cross-functional support, with emphasis on manufacturing areas.
• Support the definition and execution of inspection readiness activities, including participation in site self-inspections and global quality audits.
• Lead project initiatives in support of both the project and the Quality function.
• Resolve or escalate compliance issues to project leadership, site leadership, and Quality Management as appropriate.
• Provide guidance for deviation handling, observation responses, change control proposals, and document creation and revision.
• This above bullet is the most crucial aspect of the JD

Minimum Requirements:

• 3 years of experience in pharmaceutical Quality or pharmaceutical manufacturing.
• Previous experience with C&Q / Verification and Validation oversight, including automation and computer systems validation.
• Demonstrated knowledge and use of US, EU, Japan, and other global regulations related to pharmaceutical manufacturing.
• Ability to work independently as a Quality Subject Matter Expert with minimal supervision.
• Proficiency with computer systems including Microsoft Office products and quality systems such as TrackWise.

Education Requirements:

• Bachelor’s degree or equivalent in a scientific or technical field.

Additional Preferences:

• ASQ certification.
• CSQA experience.
• Previous experience with manufacturing equipment preparation, formulation, filling operations, visual inspection, device assembly, packaging, utilities, facilities, maintenance, and warehouse management.
• Previous experience with Manufacturing Execution Systems (MES).
• Previous use of KNEAT or other electronic validation software.
• Prior technical writing experience.