Quality Assurance Specialist II (QC Compliance)

$55,000 - $68,000/Yr

Sentio Biosciences - Maryland Heights, MO

Full-time - Mid Level

Maryland Heights, MO

Chemical Manufacturing

About the position

The Quality Assurance Specialist II (QC Compliance) at Sentio BioSciences LLC is responsible for ensuring compliance with cGMP standards in the quality control processes. This role involves reviewing analytical test data, managing corrective actions, and ensuring data integrity while supporting regulatory compliance and inspection readiness.

Responsibilities

• Review all QC analytical test data packets for raw materials, API, drug product, and consumables.
• Write certificates of analysis and execute batch release in compliance with cGMP internal SOPs and specifications.
• Generate, review, and approve Corrective and Preventive Action reports (CAPA), change control, and laboratory quality events.
• Drive timely closure of investigations related to Out of Specifications (OOS) events.
• Discuss data interpretation with analysts and escalate issues as necessary.
• Facilitate corrections in laboratory data or documentation with analysts.
• Create, maintain, and approve relevant SOPs for QA and QC processes.
• Drive implementation and review of data integrity controls and electronic data audit trails.
• Manage the Stability Program for commercial and R&D products in compliance with guidelines.
• Review and approve protocols and reports for Method Validation and instrument qualification.
• Ensure all QC personnel are appropriately trained.
• Maintain trend analysis for quality control activities.
• Ensure proper handling and control of working standards and test samples.
• Support inspection readiness and participate in audits.
• Compile data and analysis for QC and QA activities in the Annual Product Review.
• Execute additional projects as needed.

Requirements

• Bachelor's degree in Chemistry or Biology.
• Minimum 2 years of experience in quality control or quality assurance.
• Sound analytical skills.
• Strong math skills.
• Excellent communication skills.
• Understanding of statistics.

Benefits

• Health savings account
• Health insurance
• Dental insurance
• 401(k)
• Paid time off
• Vision insurance
• 401(k) matching