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Resumes 41 - 50 of 391 |
Raleigh, NC
... to view documents submitted to FDA) CTMS Systems (Quintiles International and CCSA Inc) One World Financial Reporting System (Viewing and reporting payments to sites) Pfizer Systems/eTMF RedCap/EDC and eTMF THERAPEUTIC EXPERIENCE Oncology (2 years); ...
- 2023 Apr 02
Cary, NC
... Rich experience on technical side in various releases of Oracle EnterpriseOne sustaining development activities with design tools like FDA, RDA, TDA, C & NER BSFN etc. Functional knowledge of HCM module like Payroll, US Year End, Canadian Year End ...
- 2023 Feb 19
Cary, NC
... PROFILE & KEY STRENGTHS Thorough understanding of FDA, GCP and ICH guidelines and its requirements Manages and provides direction to the clinical operations team Identify and communicate study-related issues Manage financial integrity of all the ...
- 2023 Feb 09
Raleigh, NC
... navigate all stages of the clinical research and FDA approval process, validation solutions end to end (DQ/IQ/OQ/PQ Validation & Documentation Protocol for FDA compliance) management of submission process, clinical monitoring and CAPA remediation. ...
- 2023 Feb 09
Durham, NC
... PCR, Cloning, Sanger sequencing, Illumina and PacBio sequencing Conducted genetic stability analysis to support drug products FDA filing for clinical trial study Screened & characterized drugs genetic variants to support clone selection in cell line ...
- 2023 Jan 22
Clayton, NC
... • Reviewed audit reporting to comply with state and federal guidelines, including safety, hazardous, materials, security, environment, FDA, OSHA etc. • Oversaw customer service and satisfaction initiatives, de-escalating complaints, elevating ...
- 2023 Jan 14
Raleigh, NC, 27603
... Maintain manufacturing specifications and process documentation and ensure compliance with GMP, FDA regulations, ISO 13485, OSHA Safety regulations and company HR policies. Utilized lean practices to balance workflow and alleviate redundancy. United ...
- 2022 Dec 16
Cary, NC
... Regulatory standards HIPAA, FLSA, ADA/ADAA, Erisa, Userra, COBRA, EEO/AAP, FMLA, OFCCP, ACA, FDA, SOX, 21 CFR Part 11 Content Management Tools MS Sharepoint, Confluence Analytical Tools Blueprint v6.4, HP Enterprise, IBM Rational DOORS, Balsamiq ...
- 2022 Nov 16
Raleigh, NC, 27604
... (PPD), Data Entry Specialist Enter course and event information for FDA. Enter AFV (accompanied field visit) information. Verify the information is entered for auditors. QC completed work. Meet deadlines, file completed work by employee numbers and ...
- 2022 Nov 05
Cary, NC
... Extensive experience in Manual testing of web and mobile applications Have worked in multiple domains like Healthcare / Pharma and FDA, ISO 13485 approved applications, 21 CFR Part 11 Regulatory testing, Computer system validation, LIMS, ELNs, ...
- 2022 Oct 30