This individual is responsible to provide QA support to the Analytical Development and Quality Control Units of a Contract Research/Manufacturing Organization, performing analytical method development and review of data generated as part of in-process and release testing of biopharmaceuticals.
Key Responsibilities include but are not limited to:
- Maintain and administer quality systems including document management, investigation/deviations, CAPA tracking, risk management, quality metric tracking, training and other quality systems
- Interface and communicate with the Client, Analytical Development teams, Technology Transfer group and the BMP Manufacturing departments in meeting project timelines, providing deliverables and resolving issues
- Perform quality review of Analytical Development documentation including raw data, test methods, protocols and executed method qualification reports.
- Support external client audits
- Perform periodic walk through audits of Analytical Development and Quality Control laboratories
- Implement continuous improvement initiatives
- Provide quality oversight of process and analytical method development in an R&D setting for client projects
- Provide quality oversight in compliance with GMPs for Quality Control testing of clinical product
- Support the Investigation and Deviation systems for tracking statuses, follow-up, and liaison with applicable department investigation writers to ensure their complete and timely resolution
- Support the CAPA Tracking System and track the timely completion and extension of commitments.
- Develop, administer and track training of the Pre-Clinical Services group
- Review and approve release and stability data, analytical testing protocols/data/reports, analytical method qualification
- Conduct review of demonstration batch documentation for accuracy and completeness, documenting deviations and/or failure investigations as appropriate
- Maintain databases and systems used for tracking various activities
- Generate, revise and review Pre-Clinical Services Standard Operating Procedures (SOPs) and other documentation as needed.
- Support regulatory (FDA, EMA) and client audits/inspections of Paragon
- Work independently under general supervision to meet company goals
- Continually evaluate systems and procedures for improvement for efficiency and compliance to applicable regulatory requirements and standards
- Other duties supporting the QA function within the Pre-Clinical Services Department
Experience & Education:
- Minimum of a B.S. in a Life Sciences discipline
- +8 years' experience within the biologic, biopharmaceutical, or regulated pharmaceutical industry
- +6 years' experience in Quality Assurance/Quality Control function reviewing Analytical testing data OR as an Analytical Chemist with some documentation review.
- Familiarity with Good Manufacturing Practices (GMPs), 21 CFR 210/211/600s, USP and ICH Guidelines
- Have the knowledge, and ability to apply basic scientific and regulatory principles utilized to solve operational, as well as routine quality tasks
- Exposure to Lean Operational Excellence highly desirable