GCP QA Auditor Jobs | Glassdoor
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GCP QA Auditor Jobs

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  • 2.5
    Agenus – Lexington, MA
    16 days ago 16d
    Principal GCPQAAuditor will define and oversee GCP audit programs. This candidate will be responsible for defining the GCP audit… communicate these to the QA team and QA management, as applicable. 2+ years of direct audit experience in GCP required Bachelors…
  • 2.5
    Glenmark Pharmaceuticals USA – Mahwah, NJ
    7 days ago 7d
    audits e.g. for cause audits, GCP audits or system audits Knowledge of the interactions required by QA throughout the lifespan of… clinical QA personnel will interact Knowledge of pharmaceutical companies and vendor organisations Knowledge of ICH GCP guidelines…
  • 3.6
    AbbVie – South San Francisco, CA
    Est. Salary $112k-$167k
    20 days ago 20d
    7 years Clinical Research Development 2-4 years QA Auditing Experience (GCP Auditing preferred) Minimum of 7 years total… assurance and GCP compliance questions from supported organizationstraining and consulting services to the organization on GCP compliance…
  • Basking Ridge, NJ
    4 days ago 4d
    of Joint audits with the Japan, EU and other DS QA Groups: Generates GCP/cGLP-QA audit tools. Assists in the preparation, documentation… Jersey at 211 Mt. Airy Road. Job Summary This GCP/GLP Auditor position prepares and supports the conduct, reporting,…
  • 3.4
    United Therapeutics Corporation – Durham, NC
    NEW
    Position Overview The GCPAuditor/Senior GCPAuditor will assure all aspects of clinical compliance and QA activities, including… and maintain a comprehensive GCP compliant quality program. Work with senior management across GCP functional areas to reinforce…
  • 2.9
    Daiichi Sankyo, Inc. – Basking Ridge, NJ
    18 days ago 18d
    Auto req ID 8787BR Job Title QAGCPAuditor Functional Area Research & Development City Basking Ridge State New Jersey… of Joint audits with the Japan, EU and other DS QA Groups: Generates GCP/cGLP-QA audit tools. Assists in the preparation, documentation…
  • 3.4
    United Therapeutics Corporation – Durham, NC
    Est. Salary $138k-$208k
    Today 8hr
    The Job Details are as follows: The GVP/GCPAuditor will manage and/or assist in all Quality Systems aspects of Clinical… Working knowledge of GVP/GCP regulations and guidelines and international regulatory practices Knowledge of QA oversight for Pharmacovigilance…
  • 3.7
    Regeneron – Tarrytown, NY
    NEW
    audit experience in GCP required Title & level (Associate Auditor, Auditor, Sr Auditor or Principal Auditor) will be determined… This position will be responsible for planning and conducting GCP audits (vendor, internal process and investigator site) and may…
  • 3.5
    Alkermes – United States
    10 days ago 10d
    Clinical QAAuditor /Manager (GCP/GPvP) Job ID 7328 Location Waltham, MA Field Locations… Safety Systems Audits Provide oversight of CQA auditors and contract auditors to develop specific audit plans, review and assess…
  • 4.5
    Green Key Resources – Ridgewood, NJ
    15 days ago 15d
    quality management system Support GCP regulatory authority inspections and provide QA support for PV regulatory authority inspections… implementation of clinical programs to clinical teams from a QA perspective Assist in the management of the Quality Management…
  • 3.4
    United Therapeutics – Research Triangle Park, NC
    NEW
    Position Overview The Senior GCPAuditor will assure all aspects of clinical compliance and QA activities, including documentation… and maintain a comprehensive GCP compliant quality program. Work with senior management across GCP functional areas to reinforce…
  • 3.8
    AbbVie Stemcentrx – South San Francisco, CA
    Est. Salary $78k-$122k
    19 days ago 19d
    7 years Clinical Research Development 2-4 years QA Auditing Experience (GCP Auditing preferred) Minimum of 7 years… assurance and GCP compliance questions from supported organizationstraining and consulting services to the organization on GCP compliance…
  • 5.0
    Xencor – Monrovia, CA
    Est. Salary $42k-$76k
    NEW
    testing in 2017 and have an excellent opportunity for a QAAuditor lll / QA Associate to join our team. We use our pioneering XmAb… corrective action. File audit reports and summaries on GMP/GLP/GCP studies. Participate in or lead external audits of GMP/GLP…
  • 3.4
    Novella Clinical – Durham, NC
    9 days ago 9d
    degree and 3 years of GCP Auditing experience are an absolute requirement. The GCPAuditor/Senior GCPAuditor will assure all aspects… Novella Clinical Resourcing is seeking a GCPAuditor/Senior GCPAuditor on a full time basis. This role will be office based in…
  • 2.9
    Covance – Princeton, NJ
    24 days ago 24d
    Posting Title Sr. AuditorQA&C Requisition ID 69197BR Job Category Quality Locations United States - Princeton, NJ… Conducts complex, directed, and/or time sensitive QA audits •Participates in global QA audits •Provides suitable recommendations for…
  • 5.0
    BioPoint – Cambridge, MA
    10 days ago 10d
    standing with regulatory agencies. Oversees all GCPQA, PVQA, and GCLP QA activities (including internal or external audit observations… seeking to hire a GCP Quality Assurance specialist for a position in Cambridge, MA. Pharmaceutical and GCP experience is required…
  • 4.0
    Johnson & Johnson – Raritan, NJ
    10 days ago 10d
    services to the people who need them. We are recruiting a QAAuditor to come and work in the Infectious diseases and Vaccines area… expert in one or more compliance disciplines or areas (e.g. GLP, GCP, PV, computerized systems, non-regulated area) and acts as a…
  • 4.1
    QualStaff Resources – San Diego, CA
    20 days ago 20d
    contract auditors, as needed. Develop proactive approaches to implement quality standards, policies and procedures for GCP regulatory… Establish overall company GCP strategy, systems, processes, programs and training. Lead Clinical QA audit activities to ensure…
  • 2.4
    Q2 Solutions – Marietta, GA
    NEW
    for an Associate Quality Assurance Auditor to join our team. Purpose: Assist lead auditors/audit liaisons in conducting, hosting… findings in the QA audit tracking database, soliciting follow-up information and closing audits/findings in the QA tracking database…
  • 4.4
    Agios Pharmaceuticals – Cambridge, MA
    20 days ago 20d
    regulations and provides GCP expert advice/guidance to staff in support of GCP operations · Acts as the GCPQA functional area representative… junior Auditors and leads GCP training activities · Maintains high degree of knowledge of global industry expectations, GCP regulations…
  • 3.8
    Juno Therapeutics – Seattle, WA
    13 days ago 13d
    collaborative and thoughtful Clinical QA organization. Job Summary: The Director QAGCP provides compliance leadership and… quality management and external auditors, in conjunction with clinical development operations to ensure GCP, GLP and GVP compliance across…
  • 2.5
    Agenus – Berkeley, CA
    NEW
    distributors for GxP compliance. Preference for auditor able to support GCP, GLP and GMP functions… audits to ensure compliance with recognized standards (i.e., GCP, GLP, GMP), regulatory authorities and in-house and external…
  • 4.4
    Agios Pharmaceuticals – Cambridge, MA
    20 days ago 20d
    junior Auditors and GCP training activities · Maintains working knowledge of industry expectations and provides GCP information… information and advice to staff in support of GCP operations · Acts as the GCPQA functional area representative for assigned clinical…
  • Addison Kenway. – Somerville, NJ
    EASY APPLY
    23 days ago 23d
    Manages clinical auditing activities performed by external GCPQAauditors and assures CQA Management those activities are performed… Manager, Clinical Quality Assessment Auditor Somerville, New Jersey Job #9529300 Seeking a leader who will be responsible…
  • 2.5
    Medpace – United States
    NEW
    Coordinate, conduct, and track company-wide regulatory training (ICH/GCP and medical device); Develop training materials and applicable… thinking and planning ability; Knowledge and application of GCP is required; Medical Device and or Phase 1 experience is a…
  • 2.9
    Covance – Indianapolis, IN
    7 days ago 7d
    Posting Title GLP/GCPQA Officer I-Bioanalytical Requisition ID 69566BR Job Category Quality Locations United States… ensure resolution. Ensures that systems used in QA are properly maintained (e.g., QA audit records, training records). Notifies…
  • 4.1
    Alpha Consulting Corp. – Edison, NJ
    NEW
    This will be on an "as needed basis. Required Skills:The QAAuditor for Computer Systems Validation Documentation should have… Experience with Quality processes (GxPs) and regulations (e.g., cGMP, GCP, and GLP regulations). The application of cGMP, cGCP, 21CFR Part…
  • 3.4
    Novella Clinical – United States
    Est. Salary $51k-$77k
    14 days ago 14d
    Novella Clinical is hiring contract GCPAuditors, nationwide. If you meet the requirement below please apply. BASIC FUNCTIONS… agendas and catering, assists auditors with arrangements, provides requested QMS information to auditors and answers routine audit…
  • 3.6
    Sunovion – Marlborough, MA
    Est. Salary $130k-$202k
    16 days ago 16d
    programs. This includes compliance to Good Clinical Practice (GCP), Good Laboratory Practice (GLP) and Good Pharmacovigilance Practices… Directs the strategic direction for the RQA function including GCP, GLP and Pharmacovigilance compliance activities. • Drives…
  • 2.9
    FivePrime Therapeutics – South San Francisco, CA
    Est. Salary $60k-$138k
    NEW
    Director, GCP Compliance. This individual will provide compliance leadership and work with quality management, external auditors, in… expert in the interpretation of GCP and GLP regulatory requirements and expectations. Conduct QA reviews of project-related Clinical…
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