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QA Specialist I or II, Data Auditor

Reference Job No. 14-34

Summary

The QA Specialist assists and supports the organization with compliance and ongoing conformance to established quality assurance processes and standards for manufacturing and packaging. Performs the review and approval of laboratory data, manufacturing records and packaging records for product release and Regulatory filings. Assists in maintaining internal controls, communications, and documentation as related to compliance with internal and external safety, quality, and regulatory standards. Facilitates internal training on quality assurance requirements, processes, and procedures. Assists with other Quality Assurance activities as required.

Location

Redwood City, CA or Research Triangle Park, NC

Responsibilities

  • Reviews/Approves laboratory data and or manufacturing and packaging records for product release
  • Performs technical review of manufacturing batch records for completeness and compliance with cGMPs as per regulatory requirements and internal procedures. This may include approval of batch records, summary reports and other release documentation
  • Performs protocol, data, and report review to verify conformance to applicable SOP and regulatory requirements
  • Reviews Regulatory Filings against primary data
  • Supports GXP compliance and inspection readiness within organization
  • Maintains internal controls over quality policies, procedures, and specifications, ensuring effective versions of procedures are available to employees for implementation
  • Facilitates changes to SOPs, policies, training materials, and other documents
  • Tracks and trends quality systems (Investigation, CAPA, training, etc.)
  • Notifies management of quality/compliance trends or failures
  • Ensures systems used in QA are properly maintained (e.g., laboratory notebooks, reports, etc.)
  • Assists during regulatory inspections
  • Other Quality Assurance activities as required

Requirements

  • A BS in Life Sciences, or equivalent
  • Minimum of two years of experience in Quality Assurance systems working in the pharmaceutical and/or biotechnology field with a focus on manufacturing, testing and release
  • Demonstrated knowledge of Quality Assurance activities and ICH and FDA/EU GxP regulations as they relate to clinical trials, product development, manufacturing, and technology transfer
  • First-hand experience in planning, writing and reviewing Standard Operating Procedures is a plus
  • Exceptional interpersonal, problem-solving, and written/verbal communication skills

Pearl is an equal opportunity employer. We celebrate and seek to build upon the diversity of backgrounds reflected by our highly motivated, talented, and productive team.

Pearl offers its full time employees a competitive set of medical and other benefits.

Qualified applicants please submit your resume to Pearlofajob@PearlTherapeutics.com and include the job reference number listed on the job description.

Principals only, please.