QA Product Specialist

Responsibilities

• Provides Quality Assurance related product leadership as it relates to planning and execution of products.
• Responsible for the collaboration, review, and approval of GMP documents.
• Represents a high-level of GMP understanding and accomplishment.
• Responsible for providing strong Quality leadership and scientific/GMP information support as the Quality representative supporting the lifecycle of products for internal and external customers.
• Responsible for clear, direct, and appropriate communication in customer interactions.
• Provide process support including process validation, technical transfer, and commercial activities. May include clinical development as needed.
• Collaborate, review, and approve product-related Change Controls, Master Batch Records, Validation Protocols and Reports, Quality Risk Assessments, Annual Product Quality Reviews, and other cGMP documentation.
• Collaborate, review, and approve minor and major investigations and Corrective Actions Preventative Actions (CAPAs).
• Create, report, and communicate product-related quality metrics to internal and external stakeholders.
• Assure that manufacturing processes, packaging, and testing comply with all regulatory filings and Corden SOPs to ensure favorable quality inspections and customer satisfaction.
• Provide Quality leadership and decision‑making on cross‑functional teams that include but are not limited to Operations, Process Engineering, Quality Control, and Safety.
• Perform final product batch disposition.
• Assist in and represent Quality during internal and external audits and regulatory inspections.
• Perform other duties as needed to support Corden Pharma initiatives and improvements.

• Bachelor’s Degree in Science and 5 years of Quality Assurance experience within the Pharmaceutical Industry; or a combination of Pharmaceutical Industry within a Technical/Operations role and academic experience.
• Project Management experience, although not required, is beneficial to this position.
• Ability to read, analyze, and interpret common scientific and analytical journals.
• Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community.
• Ability to communicate information to customers and senior management.
• Ability to effectively present information to top management and public groups.
• Ability to apply mathematical operations to such tasks as frequency distribution, determination of test reliability and validity, analysis of variance, correlation techniques, sampling theory, and factor analysis.
• Ability to apply principles of logical or scientific thinking to a wide range of intellectual and practical problems.

• Quality Assurance
• GMP
• process validation
• technical transfer
• Change Controls
• Master Batch Records
• Validation Protocols
• Quality Risk Assessments
• Corrective Actions Preventative Actions (CAPAs)
• product quality metrics

• communication
• collaboration
• leadership
• decision‑making
• problem‑solving
• presentation skills
• customer interaction
• analytical thinking
• scientific thinking
• project management