- BioAgilytix (Durham, NC)
- …Partnering with the Operations team, you will review key procedures in a GxP environment, highlight any gaps or deviations in approach, then advise on corrective ... large molecule, bioanalytical, and QA experience in a deadline-driven and regulated GxP setting. The best candidates are fast learners, quantitative thinkers, and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …but not limited to the following: all units in Patient Safety, NNI GXP Support, NNI Legal, NNI Compliance, NNI Commercial, NNI Finance, Global Business Services ... (GBS), PV & GDP Auditor (s) as well as with counterparts in Global Safety and Contract Owners in NNAS. External relationships include interactions with NNI business… more
- Actalent (Hanover, MD)
- …- RECENTLY in the past 5 years, they have been responsible for being the lead auditor for vendor audits preferably. * 3 of the recent 5 years needs to be within ... as report completion and follow up (not the supporting auditor who just takes on tasks given to them)...years, they have been responsible for being the lead auditor for vendor audits preferably. * Fluency in review… more
- Precise Solutions (Lake County, IL)
- …contributions. We currently have an immediate need for the following: Job Title: GxP IT Supplier Program Analyst Location: Lake County, IL USA Compensation: $55.00 ... resumes with candidates photo they will not be considered GxP IT Supplier Program Analyst Overview The representative for...IT Supplier Program Analyst Overview The representative for the GxP IT Supplier Program will be responsible for quality… more
- Verista (Lexington, MA)
- …skills and learn from our experiences to enhance our collective expertise Senior Quality/ GxP Auditor Responsibilities: + Execution of a Current State GAP ... Assessment of the Contamination Control Program of the client from a Global and site-specific perspective + Delivery of Current State Contamination Control Findings Report + Execution of microbial and/or cross contamination LOPA, HACCP &/or FMEA in identifying… more
- Danaher Corporation (Fargo, ND)
- …hosting and/or supporting regulatory inspections (FDA, MHRA, EMA, etc). + Qualified as an Quality/ GXP Auditor by a third party. At Danaher we bring together ... science, technology and operational capabilities to accelerate the real-life impact of tomorrow's science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power… more
- IQVIA (Indianapolis, IN)
- We are seeking a **Quality Assurance Auditor 2** to join Q2 Solutions, IQVIA's laboratory business in Indianapolis, IN. We hire passionate innovators who drive ... as we transform and accelerate research and development. As a Quality Assurance Auditor 2, you will be responsible for conducting and supporting audits, managing… more
- IQVIA (Durham, NC)
- We are seeking a **Quality Assurance Auditor 2** to join Q2 Solutions, IQVIA's laboratory business in Durham, NC. We hire passionate innovators who drive healthcare ... as we transform and accelerate research and development. As a Quality Assurance Auditor 2, you will plan, conduct, and report assigned quality assurance audits,… more
- Kelly Services (Spring House, PA)
- **Data Auditor (Quality Assurance)** Kelly Outsourcing & Consulting Group (Kelly OCG), a managed solution provider and business unit of Kelly Services, Inc., is ... currently seeking a Data Auditor ( Quality Assurance) for a long-term engagement at...and project team members/leaders Maintain the highest level of GxP compliance and evaluate department policies for efficiencies. +… more
- ThermoFisher Scientific (Middleton, WI)
- …based in Middleton, WI; so must be local to the area. + This is a support Auditor I role The QA Auditor I assures the quality of data and reports generated ... of the role.'_ **Knowledge, Skills and Abilities:** + Familiar with applicable GxP and appropriate regional regulations + Thorough working knowledge of SOPs and… more
- MicroVention, Inc. (Aliso Viejo, CA)
- **12071BR** **Title:** Sr Auditor , Clinical Quality Assurance **Job Description:** Provide support to all aspects of the Clinical Quality Assurance (CQA) function ... Standardization (ISO) 14155 and 13485), Health Canada, EU MDR, ICH GCP (E6), GxP Guidelines and Regulations. 5. Advanced working knowledge of QA principles including… more
- IQVIA (Columbus, OH)
- …concerning the activities of Quality services, results of activities, quality initiatives, GXP etc.** Ensure the follow-up of major and critical audit findings to ... maintained and up-to-date to reflect the status of audits being scheduled, auditor assignment and audit reporting and/or follow-up status.** Host customer audits,… more
- CSL Behring (King Of Prussia, PA)
- …risk mitigation strategies, managing a team of professionals responsible for GxP activities, testing excellence, evaluation and ongoing management of third-party ... audits or related activity, building relationships with the auditors, and meeting auditor expectations and timelines. + Review (and coordinate review by important… more
- Editas Medicine (Cambridge, MA)
- …Quality Risk Management exercises + Lead and support the preparation activities for GxP Compliance audits and Health Authority Inspections as needed. + Work with ... Editas is inspection ready at all times. + Support GxP Inspection Readiness assessments/plans + Promote a culture of...+ 3+ years experience conducting audits as the lead auditor + Extensive knowledge of Good Manufacturing Practices (GMPs),… more
- Actalent (Vandalia, OH)
- …members Skills & Qualifications: + ASQ Certified Quality Engineer + Lead auditor certification + Experience researching, compiling and reviewing various types of ... Strong technical / report writing skills (90% of job) + Understanding of SOP, GMP, GXP and GDP About Actalent Actalent is a global leader in engineering and sciences… more
- Actalent (Vandalia, OH)
- …Additional Skills & Qualifications: - ASQ Certified Quality Engineer - Lead auditor certification - Experience researching, compiling and reviewing various types of ... writing skills (90% of job) - Life science is a plus - Understanding of SOP, GMP, GXP and GDP - Any understanding of biologics is also a plus - Drug Manufacturing is… more
- AbbVie (North Chicago, IL)
- …medical device regulatory standards (eg MDR, IVDR, ISO, FDA, etc.). Understanding of GxP (GMP, GLP, GCP, GDP, GCLP) preferred. + Must have a technical background ... Society for Quality (ASQ) Certified Quality Manager (CQM) and/or Certified Quality Auditor (CQA). Additional Information Applicable only to applicants applying to a… more
- Bausch + Lomb (Wilmington, MA)
- …+ Strong working knowledge of FDA / ISO 13485 Quality System. requirements, GxP , and other relevant standards and regulations. + Technical skills and experience ... methods, and risk management. + Experience performing quality audits. Certified Quality Auditor (ASQ CQA) or Certified Quality Engineer (ASQ CQE) preferred. + Lean… more
