CSV QA/BA Analyst

job
  • Katalyst Healthcares and Life Sciences
Job Summary
Location
Warren ,NJ 07059
Job Type
Contract
Visa
Any Valid Visa
Salary
PayRate
Qualification
BCA
Experience
2Years - 10Years
Posted
01 Feb 2025
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Job Description
Responsibilities:
  • Functional responsibilities include ensuring accurate and timely maintenance of validation and qualification documents for all equipment and facility activities investigations and evaluation of change control.
  • Ensure IT systems are designed, setup and function in a GMP-compliant manner to safeguard and maintain the safety and quality of Client products.
  • Provides QA oversight on key software development life cycle (SDLC) processes such as problem, incident, change, release and deviations.
  • Support the Qualification and Validation activities in relation to QC and manufacturing equipment and facility design.
  • Assures appropriateness of calibration/maintenance programs, validation plans, qualification protocols, associated reports and procedures.
  • Support ECQ, Facilities, QC and manufacturing equipment-related investigations in ensuring appropriate and thorough impact assessment, root cause analysis and corrective/preventive actions are documented and implemented.
  • Ensures compliance with the site validation master plan, assist with facility start-up operations and product transfers supporting the Qualification and Validation teams.
  • Work with Engineering/Facilities/ECQ management to ensure functional activities comply with global regulatory requirements.
  • Sponsor and support the change initiatives and the implementation of process improvement initiatives.
  • Ensure site is compliant with global and regulatory data governance and data integrity requirements.
  • Support any other goals and objectives of the site Quality Assurance organization, as needed.
Requirements:
  • Must have advanced knowledge and experience with GMP, Quality and compliance.
  • Previous experience as a computer system validation / quality assurance for life sciences company regulated by the FDA is preferred.
  • Advanced level experience in design of user requirement specifications, IQ/OQ/PQ protocols, user acceptance testing and other equipment/facility qualification documentation.
  • Must be fluent in standard Microsoft Office software; experience in asset management software (e.g. Blue Mountain RAM) and quality systems software (e.g. Veeva).
  • Drives use of best practices during IT systems design, validation, and use.
  • Must be able to recognize and group technical / scientific attributes and drive science-based decisions in most technical areas.
  • Must manage development of technical or scientific initiatives and activities by interdisciplinary teams.
  • Must be able to critically review investigations and reports, interpret results, and generate technical conclusions consistent with Quality risk management principles.
  • Intermediate knowledge of quality systems including CAPA, change control, and document management systems.
  • Requires minimal direction to complete tasks, authority to make daily decisions that impact their team.
  • Negotiates solutions cross-functionally. Drives continuous improvement and improves efficiency and productivity within the group or project.
  • Consults management for advice on complex issues.
  • Able to prepare written communications and communicate problems to management with clarity and accuracy.
  • Drive strong collaboration within the site and across the network.
  • B.S. degree required.
  • 8 + years of experience in the pharmaceutical or related industry required.
  • An equivalent combination of education and experience acceptable.
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