Document Reviewer

Apex Systems; United States; Remote; USD 60,000 - 80,000; Part time

Job summary

An established industry player is looking for a remote Quality Control Document Reviewer to join their team on a part-time basis. This role is crucial in ensuring that laboratory records and study data meet regulatory standards and are scientifically sound. You will collaborate with scientists and analysts to address quality issues proactively. If you have a strong background in Regulatory Quality Control and hold an advanced degree in a related field, this opportunity allows you to contribute to impactful projects in a supportive environment while working flexibly from home.

Qualifications

• 3-5 years of experience in Regulatory Quality Control of toxicity data.
• Advanced degree in Toxicology, Chemistry, Biology, or related field.

Responsibilities

• Review laboratory records and study data for completeness and accuracy.
• Ensure compliance with test methods, procedures, and specifications.

Skills

Regulatory Quality Control

Data Analysis

Communication Skills

Education

Master’s in Toxicology

PhD in Chemistry

PhD in Biology

Tools

Excel

Job description

Apex Systems is seeking a remote Quality Control Document Reviewer for a part-time contract with one of the world's largest producers and marketers of tobacco, cigarettes, and related products.

The QC Document Reviewer will provide ad hoc technical data review with their Preclinical and Editorial Services (Regulatory Affairs) department. This role provides support as required to address data-related issues internally or in collaboration with other departments as a member of a cross-functional team.

Responsibilities

• Review (laboratory) records and study data results or calculations, both paper-based and in electronic format (e.g., Excel), including audit trails, for completeness and accuracy.
• Ensure the assay records and related information are compliant with test methods (e.g., OECD), procedures (e.g., GLP), specifications, cGMP, and applicable SOP requirements and scientifically sound.
• Communicate with Scientist(s), Analysts, and Manager(s) to proactively address quality impacting issues.
• Perform other duties as assigned; it is anticipated that all required data (cleaned and de-identified, as required) will be provided to the employee, in addition to training & instructions, by client, where appropriate.

Qualifications

• Must have 3-5 years of experience with Regulatory Quality Control of toxicity data/results in Vitro and in Vivo data/results.
• Master’s or PhD in Toxicology, Chemistry, Biology, or related field needed (Retiree or student in process of obtaining PhD in current field).

Seniority level

• Mid-Senior level

Employment type

• Part-time

Job function

• Quality Assurance