QA COMPLAINT SPECIALIST - Austin, TX - KatalystHLS

QA COMPLAINT SPECIALIST - Austin, TX -KatalystHLS

https://www.indeed.com/viewjob?t=qa+complaint+specialist&jk=799a5181abb5988c&_ga=2.154170872.1335194151.1562012451-1429968906.1557248850

Clinical Reporting Lead (Client: Allergan) - Irvine, CA - KatalystHLS.com

Under the direction of management, the Clinical Reporting Lead will lead the design, development, validation, rollout of reports/dashboards using business intelligence tools (e.g., Spotfire, J-Review, Power BI) and programs (e.g., SQL, PL-SQL, R, SAS) used in Clinical Research and Development studies. Additionally

https://www.indeed.com/viewjob?t=clinical+reporting+lead+client+allergan&jk=5a5bf866eb873482&_ga=2.120609096.1335194151.1562012451-1429968906.1557248850

QA Complaint Specialist (Client: Allergen) - Pleasanton, CA - KatalystHLS.com

The primary responsibility of this position is the investigation, analysis, resolution, trending of all complaints. Specific responsibilities include; maintaining the complaint files and providing excellent customer service. Essential Duties and Responsibilities include the following.

https://www.indeed.com/viewjob?t=qa+complaint+specialist+client+allergen&jk=adea9890a77c68a8&_ga=2.186260585.1335194151.1562012451-1429968906.1557248850

DOCUMENTATION COORDINATOR II, (Client: Allergen) - Somerville, NJ - KatalystHLS.com

We are looking for a new round of candidates. The main things the previous candidates were lacking were more around the data collection and data migration activities. The couple of candidates who did have these skills didn\'t not have them with a Quality system (e.g. doc management system, TrackWise, etc.), they were more along the business systems such as Oracle or SAP. We are looking for candidates with documentation management experience within EDMS systems. They need to be well versed in data collection, metrics reporting, TrackWise workflow have experience with performing data analysis and data migration activities for enterprise scale Quality systems (1-2 systems preferred).

https://www.indeed.com/viewjob?t=documentation+coordinator+ii+client+allergen&jk=6d4fc10cb8eb7fa6&_ga=2.143160821.1335194151.1562012451-1429968906.1557248850

Technical Writer II - Irvine, CA - KatalystHLS.com

Gathers, analyzes, and composes information provided by subject matter experts (SME). Conducts research and ensures the use of proper technical terminology. Translates SME information into clear, readable documents and process maps to be used by users Ensures consistency, clarity, and quality in and across all types of documentation. Engages in formatting, editing, and quality assurance on own work and the work of others.

https://www.indeed.com/viewjob?t=technical+writer+ii&jk=85e837b80ee206e2&_ga=2.142818421.1335194151.1562012451-1429968906.1557248850

Regulatory Affairs Specialist- IVDR - Houston, TX - KatalystHLS.com

The Regulatory Specialist will support the Hematology, Urinalysis, and Flow Cytometry business units in meeting conformity to the EU In Vitro Diagnostic Regulation (IVDR). As a regulatory process expert supporting the IVDR teams, implements regulatory strategies for IVDR activities; Provides regulatory leadership in experimental designs, data analysis and product labeling as related to registration and commercialization of in vitro diagnostic devices; collaborates with the regulatory staff from other business units, companies, government agencies and Product Regulatory Subcommittees as needed to develop harmonized policies, procedures and work instructions for IVDR compliance.

https://www.indeed.com/viewjob?t=regulatory+affairs+specialist+ivdr&jk=ecb574eed39421f2&_ga=2.75632981.1335194151.1562012451-1429968906.1557248850

Quality Assurance –CSV - South Plainfield, NJ 07080 - KatalystHLS.com

The candidate must have experience in Quality Assurance –CSV area and be familiar with FDA guidelines and GAMP regulations. 6-8 years experience in QA area is preferred. Must possess excellent communication skills including working well with others and writing skills.

https://www.indeed.com/viewjob?t=quality+assurance+csv&jk=454dfa0691dbbfe1&_ga=2.113389639.1335194151.1562012451-1429968906.1557248850