Quality Control Specialist
Remote · United States
United StatesRemoteFull TimeMid LevelBachelors DegreeUnknown
Type
Full Time
Level
Mid Level
Education
Bachelors Degree
Company size
Unknown
Job Summary
Quality Control Specialist to oversee QC activities for a drug-device combination product, focusing on device components and finished product. Responsible for reviewing batch records, DHRs, and CoAs from contract manufacturers, coordinating QC testing and release decisions, ensuring GMP/GDP/data integrity, and collaborating with cross-functional teams to resolve documentation issues and support investigations. Remote-friendly role with emphasis on external-partner QA activities and documentation management.
Required 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
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