Bioanalytical Report Writer — GLP/GCP Compliance

Resolian; Malvern (Chester County); On-site; USD 80,000 - 110,000; Full time

Job summary

Resolian is a global CRO providing GLP/GCP bioanalytical and analytical services across the US, UK, and Australia. The role requires knowledge of regulatory guidelines and the ability to prepare quality study documentation and communicate findings from study data.

You will oversee the report lifecycle, address QA audits, and manage client submissions, using LIMS and other data systems while collaborating with scientific teams and adapting to changing timelines.

Qualifications

• Knowledge of GLP, GCP, 21CFR Part 11 and GDP regulations.
• Demonstrated ability to write scientifically and technically.
• Ability to work in a regulated environment and in a team.

Responsibilities

• Oversee report lifecycle and QA audits.
• Prepare data, charts, and figures for reports.
• Communicate study findings clearly to clients.

Skills

GLP/GCP standards

SOPs & Study Documents

GDP & GDP practices

Regulatory guidelines

Communication of findings

Team collaboration

Microsoft Office

Education

BA/BS in science or related field

Tools

LIMS

Microsoft Office

Job description

Resolian is a global CRO providing GLP/GCP bioanalytical and analytical services across the US, UK, and Australia. The role requires knowledge of regulatory guidelines and the ability to prepare quality study documentation and communicate findings from study data.

You will oversee the report lifecycle, address QA audits, and manage client submissions, using LIMS and other data systems while collaborating with scientific teams and adapting to changing timelines.