Quality Assurance Manager

Title: Quality Assurance Manager

Summary: The Quality Assurance Manager is responsible for all quality related functions and documents, including implementation, coordination and direction of the Company's Quality System, that is designed to ensure continuous production which is consistent with established standards at the Majestic, PA BioSpectra Facility.

Major Roles & Responsibilities:

• Manages the review and approval of Batch Records including all documentation associated with the release of the manufactured product.
• Performs investigations on non-conformances or quality review of investigation reports completed by other departments.
• Manages and approves discrepancy and laboratory investigations.
• Communicates any quality related requirements or findings to applicable department staff to ensure the correction or prevention of non-conforming events.
• Performs implementation and closure of quality related corrective action preventative actions (CAPA).
• Performs review and approval of Product Quality Reviews in accordance with ICH Q7 Guidelines.
• Ensures compliant execution of the change management program including drafting, review and approval of change control forms and implementation and follow up on approved changes.
• Creates, reviews and approves quality system documents in the electronic document management system.
• Review and approval of Stability Data and Reports, ensuring support of established shelf life for all BioSpectra products.
• Approves and monitors the usage of regulated inventory in Sage ERP system.
• Recommends modifications of existing quality or production standards to achieve optimum quality within limits of manufacturing capability.
• Ensures Quality records are accurate, approved and in compliance with cGMP standards.
• Ensures that the facility is functioning in accordance with established quality policies and procedures through document review and approval, quality walkthroughs, communication with personnel and training support.
• May perform preprocess room inspections as needed.
• Maintains and demonstrates understanding of established quality policies, ICH Q7 Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients, Title 21 CFR Part 11 and IPEC-PQG The Joint Good Manufacturing Practices Guide for Pharmaceutical Excipients.
• Creates, manages and submits KPI reports to senior management.
• Other duties may be assigned as deemed appropriate by management.

Qualifications:

• Four-year degree in Science or related field or approved equivalent experience in a cGMP environment.
• Has knowledge and understanding of cGMP & ICH Q7
• Knowledge of relevant software applications including MS Office and Minitab
• Knowledge of office systems and procedures
• Ability to communicate effectively with customers, regulatory agencies or member of the business community regarding inquiries or complaints.
• Organized, Thorough, Neat
• Confidentiality