Technical Writer

Thermo Fisher Scientific•Allentown, PA

5d•Onsite

About The Position

The Clinical Quality Assurance Specialist II 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. The Quality Assurance Specialist II 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.

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.
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.

Nice To Haves

Trackwise experience preferred

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.
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.