QC Scientist

QC ScientistWork Location: Brazoria County, TexasSummary:Seeking a QC Scientist to provide expertise in analytical sciences, quality control, and pharmaceutical development. This role involves supporting CMC projects, managing regulatory documentation, and ensuring compliance with industry standards.

Responsibilities

Deliver subject matter expertise in analytical sciences, quality control, stability, and process scale-up for pharmaceutical development projects.Manage projects related to CMC services and analytical sciences, ensuring timely completion and adherence to quality standards.Draft, format, and review regulatory documents and technical reports, including INDs, NDAs, ANDAs, BLAs, and method validation protocols.Validate and commission equipment in a GMP environment, supporting control system validation and compliance activities.Develop and validate HPLC methods for assay, impurity, and reference standards, and conduct method transfers as needed.Perform release and stability testing on samples under GMP/GLP specifications, ensuring accurate and reliable results.Support quality compliance activities, including deviation investigations, change control coordination, and complaint investigations.Prepare and maintain reports, SOPs, change controls, and protocols for both internal and external stakeholders.

Qualifications

Bachelor’s degree in engineering or science, with coursework or experience in GMP analytical expertise.5 to 7 years of experience in development and/or manufacturing within the pharmaceutical, biotechnology, combination product, or medical device sectors.Demonstrated expertise in pharmaceutical, biotechnology, combination product, or medical device environments.Experience with pre-filled syringes, autoinjectors, co-packaged kits, drug delivery platforms, or combination product platforms is preferred.Familiarity with risk management and data analysis tools and applications.Understanding of ISO 13485 and FDA QMSR requirements.