cGxPServe

Job Description: The Division of Enterprise Technology (DET) manages the states information technology (IT) assets and uses technology to improve government efficiency and service delivery. DET administers enterprise solutions and consults on technology services for state agencies loc المزيد...

Roles & Responsibilities: Responsible for the dispensing of raw materials liquids and powders (hazardous and nonhazardous) acids/bases under cGMP conditions to support the manufacture of therapeutic proteins (API). Individual will be required to perform and monitor all dispensing pro المزيد...

Job Description: Histology Technician II is responsible for understanding and proficiently performing routine histology technique while employing good documentation practices (GDPs) in recordkeeping to support Quality Control Product Release Testing. This includes but is not limited المزيد...

Responsibilities: The Senior Statistical Analyst is a key role in the research and development of new pharmaceutical products. The primary responsibilities for this role include the analysis and reporting of clinical trial data and leading the statistical programming activities for المزيد...

Job Summary : We are seeking a highly experienced Quality Engineer IV to support quality systems compliance within the medical device industry. This role focuses on managing quality systems integration regulatory support CAPAs and audits. The position is 100 onsite and local candida المزيد...

Responsibilities: Participate in the of protocol activities of a Phase I clinical research study conducted at the Phase 1 Unit. Maintain safety and confidentiality of study subjects throughout the study. Evaluate adverse events and manage safety reporting activities in a timely man المزيد...

Roles & Responsibilities: Minimum experience of 4 years in Medical devices Manufacturing Engineering. Good Experience working on Process Validations (IQ OQ PQ. . Experience developing manufacturing processes and technologies which includes process characterization. Experience worki المزيد...

Responsibilities: The main function of a clinical data analyst is to create moderately complex metrics to identify trends in data and remediation utilizing tools (e.g. systems reports) to assess the need for training and provide basic recommendations to improve data status during st المزيد...

Responsibilities: Lead requirement gathering sessions with crossfunctional stakeholders. Identify business needs and translate them into analytics and reporting requirements. Author GxP and nonGxP documentation including URS FRS design specs system support plans and business continui المزيد...

Roles & Responsibilities: Bachelors degree in engineering or a related technical discipline required. Minimum 5years of experience in procurement sourcing and supplier management. Proven success in sourcing within electromechanical components or complex assemblies. Medical device pha المزيد...

Roles & Responsibilities: Serve as the primary system administrator for one or more Veeva Vault applications (e.g. QualityDocs RIM eTMF PromoMats MedComms). Configure Vault objects fields page layouts workflows security roles and permissions. Manage user accounts groups profiles acc المزيد...

Roles & Responsibilities: Plans and coordinates distribution of goods to ensure that current inventory levels are within set parameters to meet customer demands. Plans and forecasts for future inventory levels based on sales forecast current inventory levels and outstanding purchase المزيد...

Responsibilities: Lead the design development and maintenance of the MHN Analytic Platform. Manage mentor and ensure technical and analytical development of a team of analysts. Work with teams to operationalize analytic and reporting innovations. Evaluate BI and machine learning solu المزيد...

Roles & Responsibilities: Perform all routine tasks to convert planned orders into material plans including the creation and management of material planned requirements. Liaison with Supply Planner and Schedulers to ensure all material plans are up to date and responsive to changes المزيد...

Responsibilities: The senior programmer position will be responsible for manipulating large databases and generating reports to enable analysts to explore real world healthcare data assets. Candidates must have excellent SAS and SQL programming skills and the ability to implement co المزيد...

Roles & Responsibilities: Process Validation (IQ/OQ/PQ). Product development experience. Process development. Process Layout Modeling and Documentation. Equipment and Tooling Development. Process Development and Characterization. Test Method Development and Validation. Developing / U المزيد...

Responsibilities: Responsible for the oversight of all data management CRO activities supporting companys clinical programs from database startup through database lock and CSR/submission. Serves as primary point of contact with the DM CROs 3rd party vendors and internal study teams. المزيد...

Job description: Uses scientific education and analytical chemistry experience to perform simple to moderately complex laboratory testing within a good manufacturing practices laboratory to generate results. Interprets data output to determine conformance to specifications. Acts as a المزيد...

Position Overview: Looking for an individual with experience in validations particularly with USP Water chiller (utilities) and C&S. Responsibilities: Generation of qualification / validation documents of qualification / validation documents generation of reports adhering to proj المزيد...

Responsibilities: Contributes to the FDA regulatory submission process; may aid in authoring and/or publishing electronic submissions. Leader in the development of dossiers for registration of products in countries outside the US; including authoring and/or publishing electronic subm المزيد...