Quality Technician

Contract position based out of Vandalia, OH.

Application deadline: Oct 8, 2026.

Responsibilities

• Perform issuance of controlled documentation in accordance with established procedures.
• Review batch production records and manufacturing records to ensure they are organized, quickly retrievable, accurate, complete, and free of errors, following Good Documentation Practices (GDP).
• Support chain of custody activities for bulk and labeled drug products, ensuring traceability and compliance.
• Assist cross-functional teams in problem solving and root cause analysis for quality events.
• Provide Quality Management System (QMS) operations support to all cGMP departments.
• Work within the Quality Management System and Enterprise Resource Planning (ERP) applications to execute quality-related tasks.
• Perform material inspection activities to support processing and distribution sites, including incoming material inspections, in-process inspections, and finished product inspections.
• Maintain accurate, complete, and compliant records of all activities, following Good Documentation Practices.
• Ensure work is completed productively and effectively both independently and in collaboration with other departments.
• Collaborate with internal customers to understand priorities and align daily activities with operational needs.
• Complete all assigned training requirements on time and apply training to daily responsibilities.
• Work with peers and management to ensure compliance with all Quality Management System requirements and applicable regulations, including but not limited to FDA 21 CFR Parts 11, 210, 211, 1271, and 820, ISO standards, AATB guidelines, and NABP requirements.
• Support internal and external audits as assigned, providing documentation, explanations, and follow-up actions as needed.

Requirements

• High school diploma or equivalent.
• Prior experience working under GMP (Good Manufacturing Practice) or GDP (Good Documentation Practice) regulations.
• Experience following Standard Operating Procedures (SOPs) and Work Instructions.
• Experience in quality control, including reviewing and maintaining quality documentation.
• Experience with document control in a regulated environment.
• Familiarity with compliance requirements in pharmaceutical, biologics, or related regulated industries.
• Ability to work with products such as medical devices, human tissue-based products, biologics, and related materials.
• Proficiency with Microsoft applications, including Word, Excel, PowerPoint, Teams, and Outlook.
• Strong attention to detail and accuracy in documentation and recordkeeping.
• Ability to perform inspections and assessments of materials and finished products.
• Capability to work independently under limited supervision while collaborating effectively with cross-functional teams.

Qualifications

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