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Quality Assurance Specialist II/III

Company: Tergus Pharma
Location: Raleigh
Posted on: November 11, 2019

Job Description:

Job Purpose: This position contributes to the Company's success by ensuring compliance with GMP/GLP regulations and internal procedures within a GMP/GLP analytical and manufacturing facility.
Summary of Key Responsibilities:

  • Review and approval of analytical documentation including methods, validation protocols, analytical data and reports (release, stability and validation).
  • HPLC data review in Waters Empower 3
  • Maintain and support completion of, including but not limited to, SOPs, Specifications, MBRs, LIRs, OOS, Deviation, CAPA, Complaints, Change Control, Equipment Qualification/Validation, Methods and Protocols
  • Track and trend quality system metrics such as LIR/OOS, DEV, CAPA, Change Control and Customer Complaints.
  • Perform CAPA review, approval and effectiveness checks.
  • Support the vendor qualification program (documentation, audits, etc.).
  • Perform facility and quality system audits.
  • Quality Assurance review and approval of instrument/equipment calibration documentation, investigations, deviations, CAPAs and change controls.
  • Quality Assurance review and approval of manufacturing documentation, including specifications and release, batch records, and batch release.
  • Other duties as assigned
    Required Qualifications and Skills
    • B.A. or B.S. in a scientific discipline.
    • 4 - 6 years' experience in a Quality Assurance / compliance role in a GMP/GLP-compliant pharmaceutical, analytical environment
    • 2+ years of analytical laboratory experience and/or process manufacturing knowledge
    • Experienced using Waters Empower 3 software.
    • Proven ability to review and evaluate the content of documentation; conscientious about attention to detail; uses logical thinking that is well organized and methodical
    • Proven ability to collaborate with technical staff with minimal management
    • Able to multi-task productively, applying time management processes and procedures effectively
    • Technically capable of determining what is wrong in complex situations and offering potential solutions, identifying root cause of a problem and working with others to correct problems
    • Works toward common goals by supporting, encouraging and sharing information with colleagues
    • Speaks, writes, listens and presents information in a logical and articulate manner

Keywords: Tergus Pharma, Raleigh , Quality Assurance Specialist II/III, Other , Raleigh, North Carolina

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