QA Specialist - II*

About the role

We are seeking a highly motivated Quality Assurance Specialist II to support quality operations and ensure compliance with applicable regulatory requirements, quality standards, and internal procedures. This role is responsible for overseeing quality systems processes, supporting investigations, and partnering with cross-functional teams to maintain product quality and operational excellence.

Responsibilities

• Provide Quality Assurance oversight and approval for deviations, out-of-specification (OOS) investigations, and change control records of moderate to high complexity.
• Ensure quality records are appropriately initiated, investigated, documented, and closed within established timelines.
• Review and approve Corrective and Preventive Action (CAPA) records and effectiveness verification activities, ensuring timely implementation and resolution.
• Monitor and ensure proper escalation of quality events and deviations in accordance with established procedures.
• Identify and implement process improvements to enhance the efficiency and effectiveness of deviation and CAPA management processes while maintaining compliance.
• Partner with manufacturing, quality control, engineering, and other functional groups to resolve issues related to product quality, manufacturing processes, facilities, equipment, materials, and environmental monitoring.
• Support ongoing compliance initiatives and contribute to a culture of quality and continuous improvement.
• Perform additional duties and special projects as assigned.

Requirements

• Master's degree in Biological Sciences or a related field; OR
• Bachelor's degree in Biological Sciences or a related field with 2+ years of relevant experience; OR
• Associate degree in Biological Sciences or a related field with 4+ years of relevant experience; OR
• High school diploma/GED with 5+ years of relevant experience in a regulated life sciences environment.

Preferred Qualifications

• Experience in Quality Control with exposure to analytical, virological, and/or microbiological testing.
• Working knowledge of current Good Manufacturing Practices (cGMP) and applicable U.S. and EU regulatory requirements.
• Experience managing or supporting deviations, CAPAs, change controls, and quality investigations.
• Strong collaboration, relationship-building, and problem-solving skills.
• Proficiency with Microsoft Office applications, including Word, Excel, and PowerPoint.
• Excellent verbal, written, and interpersonal communication skills.
• Ability to prioritize effectively and adapt to changing business needs in a fast-paced environment.
• Strong attention to detail and commitment to quality and compliance.

Schedule

Standard work schedule is Monday through Friday.

Flexibility to support occasional evening, overnight, or weekend activities may be required based on business and manufacturing needs.

Benefits

Full-time employees are eligible for benefits options such as health coverage, life insurance, disability insurance, and 401k benefits.