Katalyst CRO
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LIMS Master Data Specialist
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Katalyst CRO 2 months ago Be among the first 25 applicants Join to apply for the
LIMS Master Data Specialist
role at
Katalyst CRO Get AI-powered advice on this job and more exclusive features. Position Summary
Responsible for the creation and execution of computer system validation document as well as providing operational support and guidance related to system use and improvement. Position Summary
Responsible for the creation and execution of computer system validation document as well as providing operational support and guidance related to system use and improvement.
Responsibilities
Create and execute computer system validation documents (i.e., UAT, URS, OQ, PQ, etc.) as applicable and guide QC end users on the development of system enhancements with user requirements and business drivers. Provide electronic systems operational support and troubleshooting to end user. Create, deploy, review, and sustain electronic systems Master Data. Perform data verification, system integration (LIMS, ERP, and MES) for electronic systems. Own project, CAPA and deviation/ investigation related tasks and/ or continuous improvement efforts. Propose and implement improvements to electronic systems to optimize business process and improve efficiency. Collaborate with end users to develop business case. Anticipate mid- to long-term business needs and constraints. Support QC management in proposal and implementation of strategic initiatives. Anticipate and perform troubleshooting and problem solving independently. Train and mentor others on electronic systems use and operation. Translate business requirements into technical design requirements and communicate to partner organizations (e.g., IT) for system solution. Facilitate design, testing and subsequent deployment of solutions. Support health agency inspection as equipment area subject matter expert. Perform other tasks as required to support the electronic systems.
Requirements:
Bachelor's degree required, preferably in science or related engineering field. 6+ years of relevant work experience in LIMS, ELN and laboratory data analysis systems preferably in a regulated environment. Knowledge of analytical and microbiological test methods and environmental monitoring programs preferred. Demonstrated technical writing skills. Demonstrated experience with validation and/or maintenance of laboratory information systems.
Specific Knowledge, Skills, Abilities:
Ability to accurately and completely understand, follow, interpret, and apply Global Regulatory and cGMP requirements. Ability to work in a fast-paced team environment, meet deadlines and prioritize work. Advanced technical, problem-solving skills and logical. Ability to communicate effectively with peers, department management and cross-functional peers. Mentoring, coaching, influencing, negotiating and personnel interaction skills. Must Haves Create, deploy, review, and sustain electronic systems Master Data. Perform data verification, system integration (LIMS, ERP, and MES) for electronic systems. Seniority level
Seniority level
Mid-Senior level Employment type
Employment type
Contract Job function
Job function
Information Technology Industries
Pharmaceutical Manufacturing Referrals increase your chances of interviewing at Katalyst CRO by 2x Sign in to set job alerts for Master Data Specialist roles.
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New York City Metropolitan Area $200,000.00-$250,000.00 3 weeks ago New York, NY $61,152.00-$82,992.00 3 weeks ago New York, NY $125,000.00-$150,000.00 2 weeks ago New York City Metropolitan Area $110,000.00-$125,000.00 2 weeks ago Newark, NJ $61,152.00-$82,992.00 3 weeks ago New York, NY $105,000.00-$125,000.00 3 months ago New York, NY $120,000.00-$170,000.00 1 month ago Were unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI. #J-18808-Ljbffr
LIMS Master Data Specialist
role at
Katalyst CRO 2 months ago Be among the first 25 applicants Join to apply for the
LIMS Master Data Specialist
role at
Katalyst CRO Get AI-powered advice on this job and more exclusive features. Position Summary
Responsible for the creation and execution of computer system validation document as well as providing operational support and guidance related to system use and improvement. Position Summary
Responsible for the creation and execution of computer system validation document as well as providing operational support and guidance related to system use and improvement.
Responsibilities
Create and execute computer system validation documents (i.e., UAT, URS, OQ, PQ, etc.) as applicable and guide QC end users on the development of system enhancements with user requirements and business drivers. Provide electronic systems operational support and troubleshooting to end user. Create, deploy, review, and sustain electronic systems Master Data. Perform data verification, system integration (LIMS, ERP, and MES) for electronic systems. Own project, CAPA and deviation/ investigation related tasks and/ or continuous improvement efforts. Propose and implement improvements to electronic systems to optimize business process and improve efficiency. Collaborate with end users to develop business case. Anticipate mid- to long-term business needs and constraints. Support QC management in proposal and implementation of strategic initiatives. Anticipate and perform troubleshooting and problem solving independently. Train and mentor others on electronic systems use and operation. Translate business requirements into technical design requirements and communicate to partner organizations (e.g., IT) for system solution. Facilitate design, testing and subsequent deployment of solutions. Support health agency inspection as equipment area subject matter expert. Perform other tasks as required to support the electronic systems.
Requirements:
Bachelor's degree required, preferably in science or related engineering field. 6+ years of relevant work experience in LIMS, ELN and laboratory data analysis systems preferably in a regulated environment. Knowledge of analytical and microbiological test methods and environmental monitoring programs preferred. Demonstrated technical writing skills. Demonstrated experience with validation and/or maintenance of laboratory information systems.
Specific Knowledge, Skills, Abilities:
Ability to accurately and completely understand, follow, interpret, and apply Global Regulatory and cGMP requirements. Ability to work in a fast-paced team environment, meet deadlines and prioritize work. Advanced technical, problem-solving skills and logical. Ability to communicate effectively with peers, department management and cross-functional peers. Mentoring, coaching, influencing, negotiating and personnel interaction skills. Must Haves Create, deploy, review, and sustain electronic systems Master Data. Perform data verification, system integration (LIMS, ERP, and MES) for electronic systems. Seniority level
Seniority level
Mid-Senior level Employment type
Employment type
Contract Job function
Job function
Information Technology Industries
Pharmaceutical Manufacturing Referrals increase your chances of interviewing at Katalyst CRO by 2x Sign in to set job alerts for Master Data Specialist roles.
New York, NY $124,000.00-$176,000.00 1 day ago New York, NY $140,000.00-$175,000.00 2 weeks ago New York, NY $2,000.00-$6,000.00 2 days ago Data Analyst, Global Partnerships & Content
New York, NY $124,000.00-$176,000.00 1 day ago Marketing Data Analyst, Global Partnerships
Data Analyst, Global Partnerships & Content
New York, NY $124,000.00-$176,000.00 2 weeks ago New York, NY $100,000.00-$115,000.00 1 week ago New York, NY $105,000.00-$156,000.00 1 day ago New York, NY $150,000.00-$213,000.00 4 hours ago New Brunswick, NJ $38.00-$38.00 2 months ago New York City Metropolitan Area 2 weeks ago Fund Data Analytics & Operations Specialist- $200,000-250,000 + bonus!
New York City Metropolitan Area $200,000.00-$250,000.00 3 weeks ago New York, NY $61,152.00-$82,992.00 3 weeks ago New York, NY $125,000.00-$150,000.00 2 weeks ago New York City Metropolitan Area $110,000.00-$125,000.00 2 weeks ago Newark, NJ $61,152.00-$82,992.00 3 weeks ago New York, NY $105,000.00-$125,000.00 3 months ago New York, NY $120,000.00-$170,000.00 1 month ago Were unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI. #J-18808-Ljbffr