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TECH 2, QUALITY ASSURANCE

Ensure compliance of purchased parts delivered to Service. . Utilize basic measurement tools to inspect parts (Micrometers, calipers, height gage, thread gage, scales, pin gages, etc.) . Perform inspections, checks, and follow sam...

CompanyKatalyst
AddressZelienople, PA
CategoryManufacturing
Job typeFull-Time
Date Posted 2 weeks ago See detail

Tech 2, Quality Assurance

Katalyst

Zelienople, PA

Ensure compliance of purchased parts delivered to Service. . Utilize basic measurement tools to inspect parts (Micrometers, calipers, height gage, thread gage, scales, pin gages, etc.) . Perform inspections, checks, and follow sam...

Quality Assurance Specialist

Katalyst

Chicago, IL

Responsible for performing validation of computer systems, process automation, equipment, utility systems, and/or facilities by following approved standard operating procedures (SOPs), current Good Manufacturing Practices (GMPs) a...

Systems Engineer

Katalyst

East Pittsburgh, PA

$40.64 - $48.94 an hour

Overall technical leadership and responsible for realization of full systems product release/life cycle management to ensure quality and compliance. Translation of user and business requirements into product requirements, high lev...

Sr. Clinical Trial Manager

Katalyst

Redwood City, CA

Act as the study lead delegate on cross-functional study teams, Vendor, and CRO operational meetings and ensure compliance with global operational standards and procedures. Support vendor selection, onboarding, management, and ove...

Clinical SAS Programmer

Katalyst

Cranbury, NJ

Program analysis datasets, statistical tables, figures, and listings. . Generate SDTM data sets, ADaM data sets, and Define.xml files along with all supporting documentation. . Provide statistical programming and validation suppor...

Sr. Statistical Programmer

Katalyst

Gwynedd, PA

Utilize SAS to generate and validate tables, listings, and figures (TLF) based on SAP. . Use major statistical programming language to perform data analysis for various needs. . Provide statistical analysis support for post approv...

Clinical SAS Programmer

Katalyst

Danvers, MA

Produce and validate biostatistics deliverables including CDISC datasets (SDTM/ADaM), Tables, Listings, and Figures (TLFs), and patient profiles using SAS. . Ensure high quality and accurate work in the programming process and con...

Clinical SAS Programmer

Katalyst

Decatur, GA

Independently develops SAS or other programs, and specifications (e.g. SDTM, Adam), for use in study or other analyses, such Integrated Safety Summaries. . Must be able to program defensively, check results, and consistently produ...

Clinical SAS Programmer

Katalyst

Basking Ridge, NJ

5 years of Statistical Programming experience in the Pharmaceutical, Biotechnology, and/or Contract Research Industry. Bachelor's and/or master's degree in Statistics, Biostatistics, Computer Science, Mathematics or Life Sciences....

Clinical SAS Programmer

Katalyst

Englewood Cliffs, NJ

Utilize SAS (Statistical Analysis System) for business analytics, focusing on fundamental principles. . Employ SAS, SDTM (Study Data Tabulation Model), and ADaM (Analysis Data Model) for data manipulation and analysis. . Generate...

Lab Support Specialist

Katalyst

Frederick, MD

In-depth knowledge of GxP operations as it relates to the FDA's CFR 21 Part 11 requirements and well as Good Documentation Practices (GDP). Good understanding of Windows Desktop OS support tasks (7 Win 10) and ability to set up...

QA Validation Specialist

Katalyst

Millburn, NJ

Execute and/or approve deliverables for the Site Validation Plan enabling overall strategic implementation of remediation and qualification activities within the site's commitments. . Work in close collaboration with site-based SM...

Quality Assurance Specialist

Katalyst

Lancaster, PA

Quality Assurance Specialists working in one of our distribution centers are responsible for enforcing our cGMP practices on-site. . Report any concerns or opportunities for improvement to the QA Safety & Facilities Manager. . Pro...

Quality Assurance Validation Engineer

Katalyst

Bend, OR

Review internal and external validation protocols and technical report for validation/qualification of facility, equipment, and systems . Perform validation document Gap Analysis for equipment with QC and Manufacturing Operations...

QC Lab Equipment

Katalyst

Gaithersburg, MD

Seeking proposals to support the relocation of QC microbiology and QC analytical equipment from current labs to a new facility. . This includes approximately 50 pieces of GMP equipment, primarily benchtop Lab Equipment like QC-M a...

Global Regulatory CMC Manager

Katalyst

Summit, NJ

Participate in the development of the CMC regulatory strategy for small molecules, biologics and cell therapy submissions. These submissions include health authority briefing packages, IND/CTA, BLA/NDA and MAA regulatory filings....

CMC Regulatory Affairs Manager

Katalyst

Tarrytown, NY

Lead the preparation, review, and submission of CMC sections of regulatory filings (e.g., INDs, NDAs, BLAs, MAAs, variations, renewals) to global health authorities, ensuring accuracy, completeness, and compliance with applicable...

Warehouse Operator

Katalyst

Sparks Glencoe, MD

$15 - $18 an hour

Uses a variety of equipment such as forklifts, conveyers, cranes, handcarts, and power trucks to move materials, parts, assemblies and finished products or goods within a plant, office or warehouse. May maintain records. Develops...

Electronic Product Development Engineer

Katalyst

Milwaukee, WI

Automotive, Hardware, Battery, PCB, PCBA, Printed Circuit Board Assembly, Client, Battery Management Systems, Design, Development, Testing, Validation, FuSA, Functional Safety Analysis like DFMEA, Worst Case Analysis, WCA, WCCA, A...

Multimedia Engineer

Katalyst

Philadelphia, PA

Total 7+ Years of Exp ! . Min 4+ Hands on experience with various Platform SW components for multiple embedded platform - Linux systems. . Strong C/C++ and system level Linux working experience Full stack devel...

Quality Risk Management Specialist

Katalyst

Bothell, WA

Additionally, this role supports the use of various Risk Management tools to lead complex cross-functional issue resolution by employing a methodical approach to root cause analysis and implementing appropriate corrective and prev...

Quality Engineer

Katalyst

East Aurora, NY

Develop and implement quality control processes to identify and address product or process non-conformances. . Conduct regular quality assurance audits and inspections to ensure adherence to established quality standards. . Utiliz...

QA Specialist

Katalyst

Albuquerque, NM

Develops a comprehensive understanding of the manufacturing processes and the associated risk management control strategy developed to identify process risks and associated critical controls around the associate processing steps....

Packaging Operator

Katalyst

Sparks Glencoe, MD

$15 - $18 an hour

Responsible for moving required materials from defined storage or staging areas to workspace using material handling equipment including manual and motorized pallet jacks/walkies. Packaging of final product into end-user container...

QA Validation Specialist

Katalyst

Apex, NC

Managing Quality Engineering and Validation (QEV) Validation programs for the facilities, utilities, manufacturing and QC lab equipment, computerized systems and associated processes. . Responsible for maintaining and ensuring sit...

Regulatory Strategy Consultant

Katalyst

San Rafael, CA

Provide strategic insight to the GRT regarding product development, and serve as Regulatory contributor to partner teams (eg, study execution teams, clinical development team etc.) as appropriate . In collaboration with regional r...

Clinical SAS Programmer

Katalyst

Florham Park, NJ

Creation of SAS programs to Develop or Validate SDTM/ADaM/TLFs. . Provide oversight for CRO SDTM/ADaM/TLFs deliverables for multiple studies and make sure efficiencies are gained at the project level. . Generate and/or review SDTM...

Instrument Validation Specialist

Katalyst

Rahway, NJ

Gain a working knowledge of laboratory equipment to facilitate with troubleshooting and/or communicate with the vendor/ service engineer to identify resolutions. . Participate in computer system validation activities associated wi...

Sr Quality Assurance Specialists

Katalyst

Irvington, NY

Deviations & CAPA Mastery: Leverage your 10+ years of experience handling deviations and corrective action/preventive action (CAPA) processes to lead investigations, identify root causes, implement effective remediations, and...