- Merck & Co. (Durham, NC)
- …CAPA closure.- Position requires risk communication related to the totality of audit and inspection findings at the site.- Ability to lead an audit program that is ... and other compliance topics Perform routine risk communication pertaining to audits/ inspection to Site, Regional, and Divisional Management Mentor new auditors to… more
- Merck & Co. (Durham, NC)
- …drug product, including biotech culture growth, harvest, lyophilization, product inspection , and quality control laboratories. The Quality Assurance Manager will ... Support compliance to Durham Site policies and procedures that promote Permanent Inspection Readiness (PIR). Consults on an as-needed basis with next level manager… more
- Merck & Co. (Rahway, NJ)
- …& quality requirements on GCS equipment and infrastructureSupport Permanent Inspection Readiness and Continuous Improvement expectations.Manage global small capital ... Minimum Requirement: Bachelor's degree in an engineering, scientific, or related field .-Required Experience and Skills:At least 10 years' experience in a technical… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …systemsDrive continuous improvement initiatives leveraging Lean/Six Sigma methodologies.Maintain inspection readiness and contribute to regulatory inspection ... AccountableRequirementsBachelor's degree in Supply Chain Management, Business/Engineering, or related field or equivalent work experience required.A minimum of 8… more
- Novo Nordisk Inc. (Durham, NC)
- …positions All employees enjoy generous paid time off including 14 paid holidays Health Insurance , Dental Insurance , Vision Insurance - effective day one ... to Novo Nordisk-marketed pharmaceutical products Tuition Assistance Life & Disability Insurance Employee Referral Awards At Novo Nordisk, you will find… more
- Merck & Co. (Durham, NC)
- …a bias toward going to see problems for oneself in the field as they arise. Enthusiasm for continuously learning is a requirement.Primary ResponsibilitiesSupporting ... processing operations such as formulation, filling, lyophilization, or automated inspection processesFamiliarity with process risk assessment tools, Quality by… more
- Merck & Co. (North Wales, PA)
- …who can work with urgency, is comfortable with an elevated level of inspection in a highly visible environment, and most importantly, can work collaboratively across ... not apply to, and daily in-person attendance is required for, field -based positions; facility-based, manufacturing-based, or research-based positions where the work… more
- Merck & Co. (North Wales, PA)
- …data standards including SDTM, ADaM, clinical site data for CDER inspection planning, etc.Responsible for continuous improvement of the company's electronic ... in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus 5 years SAS programming experience in a clinical trial… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …compliance.Support and manage change controls and maintain permanent inspection readiness and actively support regulatory inspections.Ensure investigations are ... investigation writing.RequirementsBS/BA required in technical discipline: Engineering, science or similar field .A minimum of five (5) years experience within a cGMP… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …and other project initiatives.Supports any business improvement efforts.Supports permanent inspection readiness and actively supports internal audits and regulatory ... RequirementsBS/BA required in technical discipline: Engineering, science or similar field .GMP Manufacturing, Warehouse and Logistics experience in the biotech/biopharma… more
