GMP Quality Control Technician – Cleanroom & Compliance

Regulatory Jobs; San Antonio (TX); On-site; USD 52,000 - 76,000; Full time

Job summary

Bone Bank Allografts, a subsidiary of Globus Medical Inc., focuses on processing and distributing bone allografts for orthopedic, dental, and reconstructive surgeries. The Quality Control Technician will support the Quality Department and in-house manufacturing to ensure regulatory conformance and adherence to company policies throughout the production process.

Essential duties include QC testing, inspections, equipment qualification, environmental monitoring, and documentation.

Qualifications

• Bachelor’s degree preferred
• Minimum 2 years’ experience in Quality Control
• Knowledge of GMP regulations preferred
• Must be knowledgeable with Microsoft Word, PowerPoint and Excel programs
• Strong typing skills, analytical skills, problem-solving techniques, excellent communication and writing skills
• Must be a flexible team player capable of working in a deadline dictated environment

Responsibilities

• Performs quality control testing on manufacturing supplies, in-process materials, finished products, etc.
• Performs in-process and final product inspections
• Drafts test reports for any test performed
• Participates in equipment qualification on new manufacturing equipment
• Performs viable and non-viable particulate environmental monitoring in cleanrooms
• Monitors temperature, pressures, and humidity in controlled environments
• Identifies non-conformances and areas for improvement
• Inspects and approves product labeling
• Helps coordinate facility equipment calibrations and preventative maintenance
• Reviews cleaning logs and steam and ETO sterilization runs
• Completes personnel environmental monitoring
• Participates in continuous improvement functions and implement changes
• Reviews processing records, test results, certifications, etc., as needed
• Performs other duties and responsibilities as necessary
• Adheres to the letter and spirit of the company Code of Conduct, the AdvaMed Code, MedTech Code, and all other company policies
• Ensures compliance with applicable governmental laws, rules, and regulations, both in the United States and internationally, by completing introductory and annual training and maintaining knowledge of compliance as it applies to your role
• Represents the company in a professional manner and uphold the highest standards of ethical business practices and socially responsible conduct in all interactions with other employees, customers, suppliers, and other third parties of Globus

Skills

Analytical skills

Communication skills

Problem-solving

Team player

Flexibility

Education

Bachelor's degree preferred

Tools

Microsoft Word

Excel

PowerPoint

Job description

Bone Bank Allografts, a subsidiary of Globus Medical Inc., focuses on processing and distributing bone allografts for orthopedic, dental, and reconstructive surgeries. The Quality Control Technician will support the Quality Department and in-house manufacturing to ensure regulatory conformance and adherence to company policies throughout the production process.

Essential duties include QC testing, inspections, equipment qualification, environmental monitoring, and documentation.