Quality Control Specialist
We are seeking a Quality Control Specialist that will support quality control activities for a drug-device combination product, with a focus on device components and finished product. This role will primarily oversee and review quality control activities performed by a contract manufacturer, ensuring compliance with specifications, GMP requirements, and regulatory standards.
Responsibilities
- Review batch records, device history records (DHRs), and associated documentation generated by contract manufacturers for accuracy, completeness, and compliance
- Coordinate and oversee QC testing activities performed by external partners, including device performance and release testing
- Review test results and certificates of analysis (CoAs) to support product release decisions
- Ensure all testing and documentation meet established specifications, methods, and GMP requirements
- Collaborate with contract manufacturers to resolve documentation issues, discrepancies, and data inconsistencies
- Support investigations related to deviations, nonconformances, and out-of-specification (OOS) results
- Track and ensure timely completion of QC-related deliverables from external partners
- Support method validation, method transfer, and specification development activities
- Maintain accurate and compliant documentation in accordance with data integrity standards
- Partner with Quality, Manufacturing, and Supply Chain teams to ensure product quality and supply continuity
Qualifications
- Bachelor's degree in a scientific or technical discipline
- 5+ years of QC experience in medical devices or combination products
- Experience reviewing batch records, DHRs, and QC documentation from external or contract manufacturers
- Familiarity with device performance testing (e.g., functional testing, dose delivery, spray characterization) preferred
- Strong understanding of GMP, GDP, and data integrity requirements
- Experience supporting investigations (deviations, OOS, nonconformances)
- Ability to work effectively in a remote environment with cross-functional and external teams
- Strong attention to detail, organization, and communication skills
Location
Employee Type
Ventura Solutions is a reputable end-to-end medical device and combination product consulting, staffing, and training firm.With our deep industry expertise spanning medical devices and combination products, coupled with an outstanding talent pool, we stand out as the preferred option for a diverse array of projects.On the consulting side, we integrate seamlessly into your team and manage small to complex Statement of Work (SOW) projects.On the staffing side, we help source, screen, and on-board reputable employees to fill temporary, temp to permanent, and permanent job openings.
We accelerate product development, keep products compliant, and help build great organizations.
Equal Opportunity Employer Minorities/Women/Veterans/Disabled
Quality Control Specialist
We are seeking a Quality Control Specialist that will support quality control activities for a drug-device combination product, with a focus on device components and finished product. This role will primarily oversee and review quality control activities performed by a contract manufacturer, ensuring compliance with specifications, GMP requirements, and regulatory standards.
Responsibilities
- Review batch records, device history records (DHRs), and associated documentation generated by contract manufacturers for accuracy, completeness, and compliance
- Coordinate and oversee QC testing activities performed by external partners, including device performance and release testing
- Review test results and certificates of analysis (CoAs) to support product release decisions
- Ensure all testing and documentation meet established specifications, methods, and GMP requirements
- Collaborate with contract manufacturers to resolve documentation issues, discrepancies, and data inconsistencies
- Support investigations related to deviations, nonconformances, and out-of-specification (OOS) results
- Track and ensure timely completion of QC-related deliverables from external partners
- Support method validation, method transfer, and specification development activities
- Maintain accurate and compliant documentation in accordance with data integrity standards
- Partner with Quality, Manufacturing, and Supply Chain teams to ensure product quality and supply continuity
Qualifications
- Bachelor's degree in a scientific or technical discipline
- 5+ years of QC experience in medical devices or combination products
- Experience reviewing batch records, DHRs, and QC documentation from external or contract manufacturers
- Familiarity with device performance testing (e.g., functional testing, dose delivery, spray characterization) preferred
- Strong understanding of GMP, GDP, and data integrity requirements
- Experience supporting investigations (deviations, OOS, nonconformances)
- Ability to work effectively in a remote environment with cross-functional and external teams
- Strong attention to detail, organization, and communication skills
Location
Employee Type
Ventura Solutions is a reputable end-to-end medical device and combination product consulting, staffing, and training firm.With our deep industry expertise spanning medical devices and combination products, coupled with an outstanding talent pool, we stand out as the preferred option for a diverse array of projects.On the consulting side, we integrate seamlessly into your team and manage small to complex Statement of Work (SOW) projects.On the staffing side, we help source, screen, and on-board reputable employees to fill temporary, temp to permanent, and permanent job openings.
We accelerate product development, keep products compliant, and help build great organizations.
Equal Opportunity Employer Minorities/Women/Veterans/Disabled
