Quality Assurance Associate - Analytical Data Review in Baltimore, MD

$80K - $100K(Ladders Estimates)

Paragon Bioservices   •  

Baltimore, MD 21201

Industry: Pharmaceuticals & Biotech

  •  

8 - 10 years

Posted 55 days ago

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

Valid Through: 2019-10-18