Quality Technician

Quality TechnicianThe Quality Technician supports quality assurance activities for manufacturing and distribution processes, ensuring that non-conforming materials and products are identified, controlled, and managed in accordance with the Quality System. This role follows all policies and procedures to maintain compliance with FDA, AATB, OSHA, ISO, and related regulatory standards. The Quality Technician works under limited supervision, handling a range of products including medical devices, sterile processed human tissue-based products, biologics, unprocessed human tissue, component supplies, and labeling materials.ResponsibilitiesPerform 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.Essential SkillsHigh 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.Additional Skills & QualificationsBachelor's degree in a Life Science or a related field preferred.Experience working in a GMP environment within pharmaceutical, biologics, or tissue processing settings.Knowledge of Good Documentation Practices (GDP) and quality documentation standards.Familiarity with biology, human tissue, and skin processing environments.Experience working with Quality Management Systems (QMS) and Enterprise Resource Planning (ERP) applications.Understanding of FDA regulations, including FDA 21 CFR Parts 11, 210, 211, 1271, and 820.Knowledge of ISO standards relevant to quality and regulatory compliance.Familiarity with AATB (Association for Advancing Tissue and Biologics) standards.Awareness of NABP (National Association of Boards of Pharmacy) requirements.Experience supporting internal and external audits.Strong problem-solving skills and experience contributing to root cause analysis and corrective actions.Ability to communicate effectively with internal customers and cross-functional teams.Work EnvironmentThis role is primarily desk-based with regular documentation and system work, complemented by hands-on inspection duties. The Quality Technician will occasionally enter clean rooms and laboratory environments and should be comfortable working around human tissue and tissue-based products. The position operates on a third-shift schedule, Monday through Friday from approximately 11:00 p.m. to 7:30 a.m. (Sunday night through Friday morning), with some flexibility required. The work takes place in a modern, state-of-the-art facility that supports a rapidly growing operation, offering exposure to advanced quality systems, cleanroom practices, and regulated manufacturing and distribution processes. Appropriate attire and adherence to cleanroom and laboratory gowning requirements are expected when entering controlled environments.Job Type & LocationThis is a Contract position based out of Vandalia, OH.Pay and BenefitsThe pay range for this position is $24.50 - $24.50/hr.Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision • Critical Illness, Accident, and Hospital • 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available • Life Insurance (Voluntary Life & AD&D for the employee and dependents) • Short and long-term disability • Health Spending Account (HSA) • Transportation benefits • Employee Assistance Program • Time Off/Leave (PTO, Vacation or Sick Leave)Workplace TypeThis is a fully onsite position in Vandalia, OH.Application DeadlineThis position is anticipated to close on Oct 8, 2026.