QC Validation Technician at Swiss American CDMO in Carrollton, TX

Pay: $22-$24

Position 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.

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.

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

Work Environment:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. The noise level in the work environment is usually moderate. The position will be located at the Swiss American CDMO manufacturing facility and report onsite daily.

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. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

The above job description is not intended to be an all-inclusive list of duties and standards of the position. Incumbents will follow any other instructions, and perform any other related duties, as assigned by their supervisor.