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Quality Assurance Specialist II/III (Lab Focus)

Company: Tergus Pharma
Location: Durham
Posted on: January 16, 2022

Job Description:

The Senior QA Specialist will contribute 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:

  • Track and trend LIR/OOS, DEV, CAPA, Change Control and Customer Complaints.
  • Perform CAPA review, approval and effectiveness checks.
  • Reviewing and approving analytical test method validations with respect to compendia and drug product intended use.
  • Stability indicating analysis trending and APR reporting.
  • Support the vendor qualification program (documentation, audits, etc.).
  • Maintain / archive all documentation, including but not limited to, SOPs, Specifications, MBRs, LIRs, OOS, Deviation, CAPA, Complaints, Change Control, Equipment Qualification/Validation, Methods and Protocols.
  • Perform facility and quality system audits.
  • Review and approval of analytical documentation including methods, validation protocols, analytical data and reports (release, stability and validation).
  • 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.
    • One or both of the following:
    • 5+ years of analytical laboratory experience wet chemistry monograph testing, DP testing (USP, EP, JP), Application: Chromatographic Data Base CDS (Empower / Open Lab), LIMs, ELN, Method Validation, Specification generation.
    • Manufacturing process knowledge batch record execution (MBR/EBR) equipment set-up, Technical Transfer, Process & Cleaning Validation protocols, Supply Chain material management ERP systems (SAP, Oracle, MS 365).
    • 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 across the organization with minimal management oversight required.
    • 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 the 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.
    • Possess computer application skills in the MS Office Suite.
      Tergus Pharma is an Equal Opportunity Employer. M/F/Vet/Age/Race/Religion/Disability/National Origin/Sexual Orientation/Gender Identity.

Keywords: Tergus Pharma, Durham , Quality Assurance Specialist II/III (Lab Focus), Healthcare , Durham, North Carolina

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