QUALITY ASSURANCE MANAGER jobs in Longview, TX

Quality Assurance Consultant - Med Device Athens, TX Quality Assurance Consultant - Med Device Athens, TX The Challenge : Responsible for developing, conducting and / or directing all microbiological, sterilization and related environmental testing and inspection operations required to assure product sterility and safety.

Provides guidance to other plant quality managers in the areas of sterilization, environmental monitoring and biocompatibility testing.

Provides work direction to lab technicians to execute Biological QA activities.

Duties and Responsibilities :

• Responsible for the development and validation of sterilization cycles and processes.
• Establish procedures for validating and monitoring product, process and environmental conditions relative to microbiological quality and safety in accordance with company procedures, standards, and regulatory requirements.
• Perform continuous research into updating procedures and all other laboratory functions in order to keep lab in overall perspective with current industrial laboratory techniques and standards.
• Oversee Microbiological / Biocompatibility efforts in support of Argon NPD / Sustaining Engineering efforts in development and design
• Evaluate microbiological test data and determine product or process validity and acceptance based on interpretation of data.
• Review and approve scientific materials as well as documentation change requests to ensure microbiological compliance in accordance with Argon policies and procedures.
• Provide support for supplier audits of sterilization facilities
• Serve as primary Microbiological contact during regulatory inspections, ensuring that plant programs are updated in accordance with Company procedures, standards, and global regulatory requirements.
• Coordinate / oversee biological testing provided by outside laboratories. Competencies
• Strong attention to detail required
• Excellent organizational, interpersonal, written, and verbal skills
• Demonstrated problem-solving skills
• Must have the ability to work and communicate effectively with others
• High level of research, analytical, problem solving skills, with strong attention to detail.
• Strong project management skills with the ability to prioritize for maximum results (multi-task management).
• Effective multi-channel communicator.
• Function successfully in a high paced results-oriented environment.
• Function well within a team environment. Supervisory responsibilities
• Supervises 3 5 laboratory and micro testing support staff
• Responsible for hiring, evaluating, disciplining, training and coaching

Essential Skills and Requirements :

• Bachelors Degree in Microbiology or Sterilization Science An advanced degree is preferred.
• Minimum 10 years of experience in microbiological / clinical / laboratory setting, with 5 years of experience working in a regulated cGMP laboratory environment
• Experience in LAL, sterility and bioburden monitoring testing.
• Experience with establishing and maintaining environmental testing programs (fluids, air, particulates) for controlled manufacturing areas.
• Sterilization validation experience using EO, gamma and e-beam in accordance with AAMI / ISO guidelines.
• Analytical chemistry experience for residual testing and other supporting analyses for plant microbiology.
• Excellent communication skills including verbal, written, and personal computing skills. High level of research, analytical, problem solving skills.

Strong attention to detail. Strong project management skills.

• Prior experience interfacing with FDA / Regulatory Agencies during inspections and technical presentations Physical demands & Travel required
• Light to medium workload. Some travel required between plants.

Last updated : 2024-04-01