The Quality Assurance Manager is responsible for managing and coordinating QA efforts in one or more divisions of the company. This position shall also implement strategies and procedures that are intended to comply with regulations governing biopharmaceuticals and pharmaceutical products as part of a quality program.
• Oversees the development, implementation, and maintenance of quality assurance systems and activities including but not limited to document control, commissioning, training, materials control, investigations, supplier qualification, compliance, CAPA, and batch record review/lot release.
• Provides written project reports as assigned by the project leader.
• Ensures timely completion of projects and project milestones.
• Coordinates and ensures training on validation equipment and materials and documentation requirements in good manufacturing practices.
• Coordinates and ensures that modular cleanrooms, their equipment, materials, layout and documentation meet good manufacturing practices.
• Responsible for training employees within and outside of the department to assure up-to-date knowledge of practices and procedures of Quality Assurance.
• Oversees qualification and validation plans for modular cleanrooms, and systems, cleaning, and process activities associated with the manufacturing of biotherapeutic and biopharmaceutical products.
• Assures that facilities, laboratory equipment, utility systems, and process equipment are validated and calibrated and that reports are properly written.
• Creates appropriate corrective action plans to prevent or correct deficiencies.
• Participates in audits and other QA tasks.
• Evaluates internal compliance with current standard operating procedures
• Oversees and reviews validation processes and procedures.
• Participates in safety programs.
• Approves validation protocols and reports.
• Makes recommendations for change and/or improvements.
• Directs the development and implementation of validation test procedures to ensure products meet validation requirements.
• Coordinates the review and revision of controlled and uncontrolled documents.
• Issues document control numbers.
• Issues approved copies of documents when requested.
• Maintains computerized files to support all documentation systems.
• Drafts initial templates and revises templates as required.Performs the calibration and validation of equipment and systems.
• Generates standard form for modular clean room equipment turnover packages and may be required to prepare the same prior to the delivery of modular cleanrooms.
Additional Desired Skills:
Bachelor’s Degree: Natural or physical science, chemical engineering, process engineering, or other related discipline
Minimum of 5 years Quality Assurance and/or compliance, experience in a biotech and/or pharmaceutical company, and experience with GxP operations
Advanced knowledge of cGMP compliance and other related regulatory requirements
Advanced knowledge in process systems associated with the manufacturing of a biopharmaceutical product
Advanced knowledge in FDA site Pre-Approval Inspections or other regulatory activities
Advanced skill in documentation and attention to detail
Advanced skill in computer functions such as word processors, spreadsheets, presentation applications, and internet usage
• Ability to make decisions and recommendations
• Ability to lead and manage professional and technical teams.
• Ability to demonstrate professionalism with personnel and management
• Collaborative team player
• Must be able to communicate effectively through oral and written communication
• Must be able to gather and analyze information skillfully
Apply online at www.gconbio.iapplicants.com or email your resume to firstname.lastname@example.org