QC Scientist

ClinLab Solutions Group; Texas; On-site; USD 110,000 - 140,000; Full time

Job summary

ClinLab Solutions Group seeks a QC Scientist to provide expertise in analytical sciences, quality control, and pharmaceutical development. The role supports CMC projects, regulatory documentation, and ensuring industry compliance.

Responsibilities include method development/validation, equipment qualification in GMP environments, and managing release/stability testing with GMP/GLP adherence.

Qualifications

• Bachelor’s degree in engineering or science with GMP analytical exposure.
• 5–7 years of development/manufacturing experience in pharma/biotech/medical devices.
• Demonstrated expertise in pharmaceutical/biotechnology or related fields.
• Experience with pre-filled syringes, autoinjectors, co-packaged kits or drug-delivery platforms preferred.
• Familiarity with risk management and data analysis tools and applications.
• Understanding of ISO 13485 and FDA QMSR requirements.

Responsibilities

• Provide SME in analytical sciences, QC, stability, and process scale-up for development projects.
• Manage CMC-related projects ensuring timely delivery and quality.
• Draft and review regulatory documents and technical reports including INDs/NDAs/ANDAs/BLAs and validation protocols.
• Validate and commission GMP equipment; support control system validation and compliance.
• Develop and validate HPLC methods for assay/impurity/reference standards; conduct method transfers.
• Perform release and stability testing under GMP/GLP; ensure accurate results.
• Support deviations, change control, and complaint investigations.
• Prepare and maintain reports, SOPs, change controls, and protocols for stakeholders.

Skills

Analytical sciences

Quality control

Stability

Process scale-up

Data analysis

Risk management

Education

Bachelor’s degree in engineering or science

Tools

GMP analytics

ISO 13485

FDA QMSR

Job description

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.