Quality Specialist II

Job Description

The QA Specialist II supports all business operations from a Quality perspective, providing oversight, strategic thinking, and results focus to reliably meet and/or exceed the site’s production targets while achieving high levels of quality. The individual is capable of partnering across the organization to manage a fast-paced production environment and deliver exceptional service to our clients. The individual also ensures business, quality and compliance goals are met in full compliance with all government-issued environmental, health, safety, quality, and regulatory policies and guidelines.

Primary Responsibilities:

• Support on the floor activities through shop floor QA procedures.
• Provide Quality input and guidance for deviations and laboratory investigations, technical documentation, program/process optimization projects, and audit readiness initiatives.
• Communicate effectively with cross functional departments to ensure on time delivery of QA review and disposition responsibilities.
• Compile batch and testing documentation and generate certificates for release of testing and manufacturing batches within assigned timelines to effectively deliver results to client.
• Ability to review data and effectively identify trends or key issues.
• Ensure facility follows current GMP standards (cGMP)
• Support the development of quality systems including a robust and on-going quality improvement system compliant with GMP.
• Complete line clearance and changeover activities to support product campaigns.
• Print master batch records to support client programs and internal manufactured products and aseptic manipulation qualifications.
• Oversee Aseptic process qualifications (APS) and vial inspections for APS and Drug product.
• Review environmental monitoring (EM) data to support changeover of suites as well as in process EM.
• Review material specs to support client programs.
• Review and approve new procedures.
• Facilitate review of document change controls for SOP revisions.

Education, Experience, and Qualifications:

• Bachelor’s degree in a commercial or scientific field required.
• Minimum of 2 years experience within Pharmaceutical/Biopharmaceutical industry.
• 1-2 years in a Quality role within Pharmaceutical/Biopharmaceutical industry is preferred.