Quality Control Technician

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., specializes in processing and distributing high-quality bone allografts for various medical procedures, including orthopedic, dental, and reconstructive surgeries. Our commitment to excellence, supported by Globus’ renowned engineering, drives our mission to advance patient care and medical innovation through precise and efficient allograft processing and distribution.

Position Summary:

The Quality Control Technician will work within the Quality Department and in-house manufacturing to assist in compliance activities of the quality system and participate in continuous improvement activities. The primary function of the Quality Control Technician will be to oversee and participate in the development, documentation, monitoring, and maintenance of the quality systems for conformance to regulatory requirements and company policies and procedures throughout the manufacturing process. The position responsibilities may include the following, although other duties and responsibilities may be assigned as necessary:

Essential Functions:

• Performs quality control testing on manufacturing supplies, in-process materials, finished products, etc., as needed (i.e., DBM testing, residual moisture, peel testing)
• 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

Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions.

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

Physical Demands:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. The employee is occasionally required to sit; climb or balance; reach above shoulder level; push/pull and stoop, kneel, crouch or crawl. The employee must occasionally lift 30 pounds and occasionally move and/or carry up 30 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.

Our Values:

• Passionate about Innovation: Improving patient care by delivering advanced technology to our customers is at the core of what we do. We are passionate about our role in improving the lives of patients by continuously developing better solutions.

• Customer Focused: We listen to our customers’ needs and respond with a sense of urgency.

• Teamwork: Working together, anything is possible. We value every person on our team and treat each other with respect. We are accountable to one another and support each other. Together, we make each other stronger.

• Driven: We pursue our mission with energy and passion. We are nimble, results-oriented, and decisive. We overcome obstacles that arise in our quest to deliver solutions that will improve the lives of our customers and patients.

Equal Employment Opportunity:

Globus Medical is an equal opportunity employer. All applicants will receive consideration for employment without regard to race, color, religion, gender, sexual orientation, age, disability, marital status, pregnancy, national origin, or citizenship. We are committed to a diverse workforce. We value all employees’ talents and support an environment that is inclusive and respectful.

Other Duties:

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.