QC Validation Technician
Swiss American CDMO
Summary
Under supervision of the Sr. Manager of Validation & Quality Continuous Improvement, the Quality Control Validation Technician is responsible for the issuance, tracking, review and oversee execution of assigned validation protocols at Swiss. In addition, the validation technician will assist in authoring and gaining approval for validation documentation as requested by Validation Management.
Job description
Essential Duties and Responsibilities
- Review and Issuance of all required Validation documentation.
- Oversee the execution of validation protocols to assure that the validation requirements are followed, and samples pulled and labeled accurately for testing.
- Tracking Validation Protocols and pertinent documentation maintaining the status for each document (i.e. Completed, in-process, final report required, obsolete, etc.)
- Organize all in-process validation/verification/qualification protocols and provide a weekly update on current status and upcoming protocol activity.
- Update validation monitoring tracking documentation for reporting to senior management.
- Provide status updates of all open protocols via validation status meeting.
- Train Operations and QC personnel on protocols before execution.
- Review and verify executed protocols to assure that all requirements are met prior to reporting.
- Coordinating with validation SMEs, quality control and production to ensure adherence to GMP requirements and alignment to overall validation strategies
- Collecting quantitative data in statistical format for use with Final Reports.
- Contributing to data, compliance and safety reviews.
- Cross training within the department stability coordinator essential duties to ensure sufficient coverage for PTO.
Qualifications: Essential Skills and Qualifications
- Minimum of 1 year of industry experience
- Must have a working knowledge of validation and quality activities in an FDA regulated environment (OTC Drug, Medical Device, Pharmaceutical Drug)
- Experience working in a regulated environment
- Strong proficiency in the use of various computer Microsoft windows-based software.
- Proficient in Microsoft office 360, Excel, Outlook, Word, etc.
- Strong problem-solving skills and a hands-on approach to problem solving
- Highly proficient organizational skills which contribute to the ability to efficiently multi-task several objectives at the same time
- Excellent technical, organizational, interpersonal, collaborative, and verbal/written communication skills
- Able to examine an issue from diverse perspectives (safety, compliance, maintenance, automation, equipment, process, and people) to best understand and resolve it
- Able to work in a collaborative work environment.
Desired Skills and Qualifications
- Associate's degree or higher in Science or Engineering discipline
- Experience executing process validations
- Experience with data analysis to show process control for validated processes
- Experience with sterilization validation of terminally sterile medical devices.
- Experience with Cleaning Validations
- Experience with Equipment Qualifications
- Experience in Quality Operations and Technical Operations
Requirements
- Minimum of 1 year of industry experience
- Working knowledge of validation and quality activities in an FDA regulated environment (OTC Drug, Medical Device, Pharmaceutical Drug)
- Experience working in a regulated environment
- Strong proficiency in Microsoft Windows-based software
- Proficient in Microsoft Office 365, Excel, Outlook, Word
- Strong problem-solving skills and hands-on approach
- Highly proficient organizational skills and ability to multi-task
- Excellent technical, organizational, interpersonal, collaborative, and verbal/written communication skills
- Able to examine issues from diverse perspectives (safety, compliance, maintenance, automation, equipment, process, people)
- Able to work in a collaborative work environment
- Associate's degree or higher in Science or Engineering discipline (desired)
- Experience executing process validations (desired)
- Experience with data analysis to show process control for validated processes (desired)
- Experience with sterilization validation of terminally sterile medical devices (desired)
- Experience with Cleaning Validations (desired)
- Experience with Equipment Qualifications (desired)
- Experience in Quality Operations and Technical Operations (desired)
Company overview
Swiss American CDMO is a full-service Contract Development and Manufacturing Organization with over 30 years of experience in delivering innovative manufacturing solutions for topical skin care, sun care, and wound care products. Headquartered in Carrollton, Texas, the company operates a 134,000-square-foot cGMP facility that serves clients worldwide. Swiss American specializes in developing and manufacturing next-generation topical formulations, including mineral-only, chemical, and hybrid sunscreen systems, with a strong focus on photostability, elegant sensorials, and regulatory compliance. The company's expertise spans from initial product discovery through commercial manufacturing, with capabilities in formulation science, regulatory affairs, and quality assurance. Swiss American's team of scientists and engineers brings extensive experience in creating novel product solutions that deliver superior performance and competitive advantages for brands in the personal care and healthcare markets. The company maintains rigorous quality standards, operating under validated systems designed to exceed FDA, ISO, and client requirements while ensuring global market compliance.