Job: Quality Assurance Specialist III, Tergus Pharma, Durham, NC
Quality Assurance Specialist III
Durham, NC 27713 United States
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
Tergus Pharma, LLC (the "Company") is proud to provide equal employment opportunities (EEO) to all individuals regardless of their race, color, creed, religion, gender identity, age, sexual orientation, national origin, disability, veteran status, genetic information, physical or mental disability, medical condition, or any other characteristic protected by state, federal or local law.
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