- 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 (Clayton, NC)
- …Provide leadership for other analysts as they execute their daily tasks. Relationships Quality Control Manager. Essential Functions + Data Trending & Tracking + ... life-changing careers, and the opportunity to help improve the quality of life for millions of people around the...departmental documents are current & standardized + Laboratory Equipment Validation & System support + Laboratory IT System support… more
- Novo Nordisk (Clayton, NC)
- …& quality systems (eg, product disposition, Deviations/CAPA, Change Control , Audits, Supplier Management, Project Management, Validation , etc.) required ... QC across all production areas in Product Supply. The area is anchored in Product Supply, Quality ...Person), if role is in batch release. Serve as Quality oversight, review & approval of validation … more
- Novo Nordisk (Clayton, NC)
- …& quality systems (eg, product disposition, Deviations/CAPA, Change Control , Audits, Supplier Management, Project Management, Validation , etc.) required ... authority (Authorized Qualified Person), if role is in batch release. Serve as Quality oversight, review & approval of validation activities associated with… more
- Astellas Pharma (Sanford, NC)
- …in Biological Sciences with 0-3+ years of relevant industry experience in a quality control role. + Experience in molecular/cell biology required (minimum 1 ... Astellas Center of Excellence for their newly created Genetic Regulation Focus Area . We are currently exploring three gene therapy modalities: gene replacement, exon… more
- Novo Nordisk (Clayton, NC)
- …Novo Nordisk (NN) procedures & requirements from health authorities are reflected in the validation planning & quality related decisions + Support validation ... standards, & Corporate/Local SOPs + Review & approve change control requests + Review & approve deviations + guidance...is required + Strong knowledge level in cGMP's & validation is required + Strong knowledge in Quality… 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
- Novo Nordisk (Clayton, NC)
- …fill & finish warehousing, and QC across all production areas in Product Supply. The area is anchored in Product Supply, Quality & IT, which globally employ ... plant operations including troubleshooting & optimization activities + Adhere to all quality & environmental regulations within area of responsibility + Drive… 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
- Grifols Shared Services North America, Inc (Clayton, NC)
- …standards and control program within the laboratory 7. Overseeing the validation of new test methods (includes drafting protocols, execution and drafting final ... reports) **Requirements:** **_- Sr. Quality Associate I:_** BS/BA degree preferably in a STEM...best practices and develops solutions to defined problems within area of assignments; Communicates effectively and promptly with all… 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
- Grifols Shared Services North America, Inc (Clayton, NC)
- …standards and control program within the laboratory + Overseeing the validation of new test methods (includes drafting protocols, execution and drafting final ... to SOP and/or best practices and develops solutions to defined problems within area of assignments; Communicates effectively and promptly with all levels of the… more
- Randstad US (Sanford, NC)
- …sterility testing will help provide safe drugs to patients. Your understanding of Quality Control instruments will help us meet their accuracy specifications ... completeness and compliance. - Serve on cross functional teams to represent Quality Control and facilitate communications and activities/projects between … 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
- Astellas Pharma (Sanford, NC)
- …Development, Quality Assurance, Process Sciences, Regulatory, CMC teams, Facilities, Validation , Supply Chain, Quality Control , and various vendors. ... of Excellence for their newly created Genetic Regulation Focus Area . We are currently exploring three gene therapy modalities:...supply of materials at the phase appropriate level of quality and grade + Drive risk assessments as required… 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