Technical Writer

Join us as a Quality Assurance Specialist II and make an impact at the forefront of innovation. This role provides broad expertise to the department in one or more specialized areas or processes within the Quality Management System (QMS).

Responsibilities

• Serve as subject matter expert for process/vendor audits or activities in several areas of expertise, e.g., review computer system validation data, lab investigations, root cause analysis, batch record review, or total Quality Management.
• Represent the department in client and regulatory inspections/audits, and lead in development, lifecycle tracking, and effectiveness measurement of corrective actions.
• Participate in inter-departmental meetings and contribute to policy-making decisions.
• Provide training for department and/or laboratory staff.
• Evaluate acceptability of data based on criteria set forth in SOPs and methods.
• Review data sample result tables and analytical reports for completeness and accuracy of data.
• Utilize department checklists to evaluate content of reports and compliance with reporting criteria.
• Verify accuracy of analytical results and sample identification, and inventories and submits data to archives.
• Review complex batch records and associated documentation for completeness and accuracy of data.
• May lead risk assessments.
• Manage set up and filing of documents.
• May mentor junior team members in area(s) of expertise.
• Act as a quality consultant to the organization in their area(s) of GxP expertise.
• Support business leaders in mitigation of risk.
• Build relationships between on-site QA services and QA management of designated clients.

Requirements

• Bachelor's degree or equivalent and relevant formal academic/vocational qualification.
• Previous lab or QA experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years). In some cases, an equivalency consisting of a combination of appropriate education, training, and/or directly related experience will be considered sufficient.

Skills

• Trackwise experience preferred.
• Comprehensive expertise in one or more specialized quality management areas, ensuring compliance with applicable international and national regulations, guidelines, and client/company requirements.
• Ability to lead vendor and internal audits, participate in client and regulatory inspections, and/or manage the administration and reporting aspects of quality management systems.
• Act as a resource for training activities and policy-making decisions.

Schedule

Standard office hours (40 hours per week). Variable work hours to accommodate schedules.

Environmental Conditions

• Work is performed in an office, laboratory, and/or GMP Depot environment.
• For laboratory positions, potential exposure to biological fluids with potential exposure to infectious organisms.
• Exposure to electrical office equipment.
• Personal protective equipment required, such as protective eyewear, garments, and gloves.

Benefits

When you join Thermo Fisher Scientific, you become part of a global team that values passion, innovation, and a commitment to scientific excellence. You’ll work in an environment where collaboration and development are part of the everyday experience—and where your contributions truly make a difference.