Quality Specialist- Chemist Wilson, NC | Katalyst HLS

Quality Specialist- Chemist Wilson, NC | KatalystHLS.com Overview: Performs a variety of chemical analysis and GMP review of raw materials, packaging components, ancillary solutions, in-process samples, finished product, and stability samples in accordance with cGMP, GLP, DEA and company policies and procedures. Performs a variety of chemical analysis and GMP review of raw materials, packaging components, ancillary solutions, in-process samples, finished product, and stability samples in accordance with cGMP, GLP, DEA and company policies and procedures. https://www.indeedjobs.com/katalysthls/_hl/en_US?cpref=JXWAtnzf3XWjLOi4YeVNLsKhmt5T2XHW0xfo-MLSiGA

https://careerportal.ceipal.com/jobs/career/24bcb4d0caa4120575bb45c8a156b651/cae82d4350cc23aca7fc9ae38dab38ab

Regulatory Manager - Mansfield, MA || Katalyst HLS

Regulatory Manager - Mansfield, MA - www.KatalystHLS.com The Regulatory Manager is responsible for the support of new product development and Regulatory Subject Matter Expert for the assigned projects and for applicable manufacturing sites, regarding design, development, validation, commercialization of products throughout the product life cycle. Prepare submissions (ie., Premarket Approvals: US Class III (PMA) and 510(k), CE marking Applications, Technical documentation, etc.) to obtain domestic filings, European regulatory approvals, and maintain existing approvals through periodic reporting, supplements/notices, Letters to File, renewals, change notifications, etc. https://www.indeedjobs.com/katalysthls/_hl/en_US?cpref=JXWAtnzf3XWjLOi4YeVNLsKhmt5T2XHWmcmo0mlELvA

https://www.indeed.com/job/regulatory-manager-def55c3b5d21ed32

Computer Systems Validation Engineer - Foster City, CA -katalysthls.com

Provide direct oversight for computer system validation from a quality assurance perspective to ensure quality and compliance requirements are met. Provide guidance on CSV validation issues and discrepancies. Support investigation of CSV defects and quality records (deviation, CAPAs). Provide support to external and internal audits related to computerized system validation activities.

https://www.indeed.com/job/computer-systems-validation-engineer-0d85543f4c7f5247

Clinical Data Manager - Gaithersburg, MD- katalysthls.com

Performs clinical data management functions in support of clinical studies. Functions to include some or all, but not limited to: data review, protocol review, case report form (CRF) design and creation, CRF review, data entry, database validation, query generation, and validation of study results. Assists in training new employees, including temporary data management personnel.

https://www.indeed.com/job/clinical-data-manager-19d2591e5e03f7ce

Validation Specialist - Titusville, NJ - KatalystHLS.com

Apply FDA, MHRA, and other applicable global health authority regulations to the development of computer systems supporting regulated business processes Follow SOPs and industry best practices Possess Expertise on Good Documentation and Good Testing Practices, in order to train those within the business that are less familiar.

https://www.indeed.com/job/validation-specialist-11fd8862b709beeb

SAS Programmer - Berkeley Heights, NJ - Katalysthls.com

Develop SAS programs for SDTM, Adam, client-defined analysis datasets, Patient Profiles, Tables, Listings and Graphs in support of the Statistical Analysis Plan, posters, manuscripts, Integrated of Summary of Safety (ISS) and Integrated Summary of Efficacy (Client) Provide technical planning to include overseeing the set-up of key macros and SAS programs. Act as a Lead Programmer for projects Represent Statistical Programming at internal and client meetings

https://www.indeed.com/job/sas-programmer-4ba1517aaeec4842

Senior Statistician - Foster City, CA - katalysthls.com

Provide sound experimental design and data analysis expertise. Author the protocol statistical sections and generate statistical analysis plans and study randomization. Review and sign-off on relevant study documents and data management and programming deliverables. Prepare mockup tables, figures and listings.

https://www.indeed.com/job/senior-statistician-d166a39817377794