Apply on Employer Site

Proclinical Staffing · 1 day ago

Analytical Documentation Specialist

Bristol, PA

Contract

Onsite

Mid Level

$30/hr - $35/hr

Proclinical Staffing is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions. They are seeking an Analytical Documentation Specialist to support analytical method development and documentation processes within a regulated environment, ensuring compliance with internal standards and regulatory requirements.

Staffing & Recruiting

Hiring Manager

Shannon Briggs

Responsibilities

Author test methods and qualification documents

Create and maintain documentation templates

Review laboratory notebooks for completion, compliance with GDP, data accuracy, and clarity

Provide technical support for separation-based assays, including HPLC (RPLC, AEX, CEX, HIC), GC, and CE-SDS

Review and provide feedback on analytical methods to ensure compliance with GMP and internal standards

Assess and review qualification protocols and reports for analytical methods being transferred to quality control teams

Support the preparation and review of development reports

Assist in generating Certificates of Testing (CoT) for development batch release and stability time points

Ensure all data and documentation meet regulatory and internal compliance standards

Qualification

HPLCGCCE-SDSGMP documentationICH guidelinesAnalytical test methodsDocument management systemsLaboratory notebooks reviewStability testingTechnical reports review

Required

Degree in Chemistry, Biochemistry, Pharmaceutical Sciences, or a related field

Experience drafting analytical test methods

Proficiency in separation-based analytical techniques such as HPLC, GC, and CE-SDS

Familiarity with method development, qualification principles, and GMP documentation

Strong experience reviewing laboratory notebooks, technical reports, and GMP documents

Knowledge of stability testing and ICH guidelines (e.g., ICH Q1A-Q1E, Q2R2, Q3A-B)

Understanding of regulatory expectations for early-phase clinical development

Preferred

Experience supporting IND filings is a plus

Proficiency in document management systems is advantageous

Company

Proclinical Staffing

At Proclinical Staffing, our life science recruitment services support our partners with permanent and contract vacancies by connecting them with specialist talent across the globe.

Founded in 2005

City of London, London, GB

51-200 employees

http://www.proclinical.com

Funding

Current Stage

Growth Stage

Company data provided by crunchbase