- Merck (Durham, NC)
- … practices for products, processes and equipment. + Partner with Operations, Quality , and Automation functional areas on validation study implementation. ... **Job Description** We are seeking a Growth and Improvement minded Validation Specialist that can help drive our Strategic Operating Priorities. + Invent | Pursue… more
- Novo Nordisk (Durham, NC)
- …for Quality approval - components/raw material, batch records, change control requests, deviations & validation documents + Performs QA presence ... shop floor. Handles release of raw materials & provides quality oversight, review & approval of validation ...provides quality oversight, review & approval of validation activities associated with minor changes to existing systems.… more
- BD (Becton, Dickinson and Company) (Durham, NC)
- …quality engineering principles (eg acceptance sampling, statistical process control , measurement/test methods, quality planning, failure investigation, design ... hypothesis testing, descriptive statistics, process capability) + Reviews and has Quality Engineering approval authority for new and modified design / process… more
- Lilly (Durham, NC)
- …and qualification activities. In addition, cross-train in the visual inspection area to support collaborative quality and production team environment. ... qualification / validation documents for equipment to ensure compliance with quality standards. + Liaison with Lilly support groups and external partners to… more
- ManpowerGroup (Mebane, NC)
- …maintenance (As required and Preventative) on machines, tools, and equipment. Helps ensure quality by making machine and control adjustments, tracking scrap, and ... Engineer and Quality Management. 1. Makes required machine and equipment control adjustments to maintain proper quality and cycle efficiency. Recommends… more
- Wolters Kluwer (Raleigh, NC)
- …disease/condition and patient-specific variables. + Perform ongoing clinical data analysis and quality control activities related to proprietary drug content and ... goals. + Maintain a high degree of currency in area (s) of clinical or domain expertise and industry knowledge...Understand the needs and expectations of the assessment and validation of client problem. Ensure quality responses… more
- Cambrex High Point (Durham, NC)
- …customer-focused scientific and manufacturing excellence, as well as our strong commitment to quality and safety, we offer a range of career and growth opportunities ... our global network of locations. Together with our customers, we aim to improve the quality of life for patients around the world. Start a career where You Matter by… more
- IQVIA (Durham, NC)
- …with appropriate supervision. + Statistical Analysis Plan (SAP) and Shells: Authors or performs quality control review (QC) of SAPs and shells. Make best use of ... tasks with a focus on accuracy. Conducts all appropriate validation requirements, according to Standard Operating Procedures (SOPs), for...report form (CRF) review. + Protocol: Authors or performs quality control (QC) review of the statistical… more
- PruittHealth (Raleigh, NC)
- …She/he is responsible for planning and directing clinical operations and quality improvement practices for designated centers. The senior nurse consultant provides ... education, mentoring and validation of required systems and processes for each center,...achieve and sustain compliance with all applicable regulations and quality outcomes. **KEY RESPONSIBILITIES:** * Annually in collaboration with… more
- Lilly (Durham, NC)
- …process improvement initiatives for Plant Process Teams as representative of the Quality function. + Approve commissioning qualification / validation documents ... make life better for people around the world. **Position Description:** The Quality Assurance Representative for the Device Assembly and Packaging team provides… more
- Amgen (Holly Springs, NC)
- …Responsibilities include effectively delivering to the site, process development team, and quality control through rapid and robust analytical testing. + Ensure ... Work closely with functions including but not limited to Drug Substance, Quality , and Manufacturing + Understand analytical methodologies to detect product … more
- Amgen (Holly Springs, NC)
- …+ Responsibilities include optimally delivering to the site, process development team, and quality control through rapid and robust analytical testing + Ensure ... analytical support to functions including but not limited to Drug Substance, Quality , and Manufacturing + Understand analytical methodologies to detect product … more
- Cambrex High Point (Durham, NC)
- …technical guidance for troubleshooting and investigating simple to complex issues in area of expertise. * Effectively resolves quality issues and concerns ... specified by QMS. * Assist with development, optimization and validation of new equipment * Supports creations of departmental...guidance documents. * Strong knowledge of safety procedures and quality compliance for assigned area * Strong… more
- Actalent (Durham, NC)
- …embrace an empowered team culture including significant interaction with manufacturing, quality , IT, and engineering groups. *Bachelor's degree or higher in ... PLCs *Demonstrated ability to build relationships with team, peers and area leads *Gather, understand, and document requirements, specifications, and requirements on… more
- Lilly (Durham, NC)
- …bodies. + Previous experience in GMP production environments. + Previous facility or area start up experience. + Knowledge of Validation / Qualification ... and work with the latest formulation, isolator, and visual inspection technology. The Quality Assurance Floor Support Specialist works as a member of the QA Floor… more
- Splunk (Raleigh, NC)
- …improvements, validate fixes + Provide training to empower teams to own web accessibility quality + Mentor and coach other engineers, share the work you are doing, ... accessibility and performance + Comfort with command-line applications, source control , testing frameworks, continuous integration and other aspects of developing… more
- Amgen (Holly Springs, NC)
- …ANC manufacturing. + Define, drive, and deliver the automation and process control strategy within Drug substance manufacturing. + Serve as an experienced advisor ... DTI, and GLAM DTI Lead. + Work with diverse groups (Manufacturing, Quality , PD, Automation, IS, EHSS, Global Engineering) and drive new business processes… more
- Amgen (Holly Springs, NC)
- …Work with global engineering, manufacturing, process development, utilities, facilities, quality assurance and validation departments in developing requirements ... sophisticated engineering techniques and/or modifications of advanced techniques within area of engineering expertise. + Apply knowledge of engineering principles… more
- ManpowerGroup (Raleigh, NC)
- …consider "floater" role MKF depending on qualifications **Skillsets:** Control -M/Batch Scheduling, Some mainframe, Datacenter Operations, Datacenter Infrastructure, ... a strong candidate with extensive experience in Command Center Operations with Control -M (or other batch scheduling application) and Mainframe z/OS experience. This… more
- Navient (Raleigh, NC)
- …and scheduling platforms like Airflow and/or Kafka + Implement and enforce data quality standards, data validation , and data governance processes to ensure data ... products. We build tools that help people feel in control of their financial future, including: + **Private student...Build DBT models to transform our raw data into high- quality data sets that produce actionable insights + Collaborating… more