Technical Writer

ThermoFisher Scientific; Allentown (Lehigh County); On-site; USD 80,000 - 120,000; Full time

Job summary

Thermo Fisher Scientific is recruiting for a Clinical Quality Assurance role in a GMP environment. The position leads inter-departmental efforts to plan and implement QMS strategies for large programs and serves as a client contact for contracted services.

The role requires Bachelor’s degree or equivalent and 5+ years of lab or QA experience, with trackwise familiarity and ability to support inspections, CAPA, and policy development across departments.

Qualifications

• Bachelor's degree or equivalent in a relevant field.
• 5+ years of lab or QA experience.
• Knowledge of QMS and regulatory inspections.
• Experience in process/vendor audits and CAPA.

Responsibilities

• Serve as subject matter expert for process/vendor audits or activities in several areas of expertise.
• Represent the department in client and regulatory inspections/audits, and lead in corrective actions.
• Participate in inter-departmental meetings and policy development.
• Provide training for department and/or laboratory staff.
• Evaluate data acceptability based on SOPs and methods.
• Review data tables and analytical reports for accuracy and completeness.
• Verify data and submit to archives.
• Review complex batch records for completeness and accuracy.
• May lead risk assessments.
• Manage document setup and filing.
• Mentor junior team members in area(s) of expertise.

Skills

TrackWise

QA expertise

Audits

Education

Bachelor's degree or equivalent

Tools

Computer System Validation

Job description

Work Schedule

Standard Office Hours (40/wk)

Environmental Conditions

Office

Job Description

Clinical Quality Assurance provides broad expertise to the department in one or more specialized areas or processes in the execution of the Quality Management System (QMS). This role involves leading and attending inter-departmental meetings related to their area of expertise to develop strategies and implementation plans. This position serves as a client contact for company-contracted services for large or significant programs and contributes to policy-making decisions as a resource in their area(s) of expertise.

What You'll Do:

• 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.
• Utilizing department checklists, evaluating 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.

Education & Experience 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 for an individual to meet the requirements of the role.

Knowledge, Skills, Abilities:

***** Trackwise experience preferred

• Provides comprehensive expertise to the department covering one or more specialized quality management areas assuring all systems, processes and their outcomes comply with applicable international and national regulations
• Guidelines and fulfill client and company requirements
• May lead vendor and internal audits, participate in client and regulatory inspections, and/or manage the administration and reporting aspects of quality management systems.
• Serves as quality consultant to the organization in their area(s) of GxP expertise
• Acting as a resource for training activities and policy-making decisions, supporting business leaders in mitigation of risk
• Being responsible for building relationships between on-site QA services and QA management of designated clients.

Working Conditions and Environment:

• 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.
• Variable work hours to accommodate schedules

Why Join Us?

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.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.