What are the responsibilities and job description for the Analytical Documentation Specialist position at Proclinical Staffing?
Analytical Documentation Specialist - Contract - Bristol, PA
Looking to uncover insights that could revolutionize the future of medicine and drive breakthroughs in patient care?
Proclinical is seeking an Analytical Development Specialist to support analytical method development and documentation processes within a regulated environment.
Primary Responsibilities:
This role focuses on ensuring compliance with internal standards and regulatory requirements while providing technical expertise in separation-based assays.
Skills & Requirements:
- 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.
- Experience supporting IND filings is a plus.
- Proficiency in document management systems is advantageous.
The Analytical Documentation Specialist's responsibilities will be:
- 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.
Compensation:
- $30 to $35 per hour
If you are having difficulty in applying or if you have any questions, please contact Shannon Briggs at s.briggs@proclinical.com
If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists please request a call back at the top of this page.
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Salary : $30 - $35