Job Description

Analytical Development Documentation Reviewer - Contract - Bristol, PA

Ready to assist in bringing life-changing treatments to the world? Join our client at the forefront of pharmaceutical innovation and make a difference!

Primary Responsibilities:

You will be instrumental in ensuring data integrity, reviewing laboratory notebooks, and supporting GMP-related documentation processes. This role requires attention to detail and a collaborative approach to meet development goals.

Skills & Requirements:

• Degree in Chemistry, Biochemistry, Pharmaceutical Sciences, or related field.
• Expertise in separation-based analytical techniques like HPLC, GC, and CE-SDS.
• Experience in reviewing laboratory notebooks and GMP documents.
• Familiarity with method development and qualification principles.
• Proficiency in document management systems is advantageous.
• Knowledge of stability testing and ICH guidelines is preferred.
• Understanding of regulatory expectations for early-phase clinical development.
• Experience with IND filings and analytical data trending is beneficial.

The Analytical Development Scientist's responsibilities will be:

• Review laboratory notebooks for completion, compliance, accuracy, and clarity.
• Evaluate the suitability of analytical methods and data for development objectives.
• Provide technical support for separation-based assays, including HPLC, GC, and CE-SDS.
• Review analytical methods for compliance with internal standards and GMP requirements.
• Assess qualification protocols and reports for methods transitioning to quality control.
• Support the preparation and review of development reports.
• Assist in generating Certificates of Testing for batch release and stability assessments.
• Ensure all data and documentation adhere to regulatory and internal compliance standards.

Compensation:

• $30 to $38 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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