Quality Assurance Specialist – Onsite | Ohio

Position Overview

We are seeking a detail-oriented Quality Assurance (QA) Specialist to support operations within a state-of-the-art manufacturing facility focused on medical device assembly and final product packaging of injectable therapies. This role plays a critical part in ensuring compliance, quality oversight, and the successful implementation of systems and processes that support commercial manufacturing.

The QA Specialist will provide quality oversight across facility startup activities, including design, installation, commissioning, qualification, and process validation. Additionally, this role will support the development and maturity of Quality Management Systems (QMS) to ensure sustained compliance and operational excellence.

This position requires onsite presence in Ohio.

Key Responsibilities

• Provide quality oversight and guidance for activities related to facility, equipment, systems, and process validation.
• Support the implementation and continuous improvement of Quality Management Systems (QMS).
• Review and approve controlled documentation, including:
• Standard Operating Procedures (SOPs)
• Validation protocols and reports
• Technical and quality documentation
• Ensure compliance with cGMP, Good Documentation Practices (GDP), and applicable regulatory requirements.
• Provide oversight for quality records such as:
• Deviations and CAPAs
• Change controls
• Work orders and related documentation
• Support batch record review and approval, including electronic batch records.
• Participate in batch disposition activities and ensure product quality standards are met.
• Evaluate compliance issues, recommend corrective actions, and ensure timely resolution.
• Support and represent Quality during audits and regulatory inspections.
• Collaborate cross-functionally with Manufacturing, Engineering, and Supply Chain teams.
• Contribute to Operational Excellence and continuous improvement initiatives, including Lean practices.

Basic Qualifications

• Master’s degree + 3 years of experience in Quality and/or Manufacturing
• OR
• Bachelor’s degree + 5 years of experience in Quality and/or Manufacturing

Preferred Qualifications

• Degree in a scientific discipline
• Experience working in GMP-regulated environments (biopharma, medical device, or related industry)
• Strong understanding of validation processes (equipment, systems, and processes)
• Experience reviewing and approving validation documentation
• Knowledge of Information Systems (IS) validation
• Experience with deviation investigations, root cause analysis, and CAPA management
• Familiarity with digital tools, data analytics, or quality engineering concepts
• Ability to work independently while effectively communicating with leadership
• Strong problem-solving and decision-making skills
• Experience working in cross-functional teams
• Excellent organizational skills and ability to manage multiple priorities
• Self-starter with the ability to drive tasks to completion

Work Environment

• Location: Ohio (onsite role)
• Industry: Biopharmaceutical / Medical Device Manufacturing

Why This Role

This is an opportunity to contribute to a high-impact, advanced manufacturing environment, supporting innovative therapies while ensuring the highest standards of quality, compliance, and operational excellence.