Our client, a world-leading Pharmaceutical Company in Pearl River, NY is currently looking for a Business Analyst / Pharma Laboratory Systems (LIMS, LabWare) / HYBRID WORK to join their expanding team.
Job Title: Business Analyst / Pharma Laboratory Systems (LIMS, LabWare) / HYBRID WORK
Duration: 18 months contract, extendable up to 36 Months
Location: Pearl River, NY
Hybrid model Pearl River. min 2 days a week onsite. some weeks can be 5 but other weeks 2. need to be flexible
Note:
The client has the right-to-hire you as a permanent employee at any time during or after the end of the contract.
You may participate in the company group medical insurance plan
Job Description:
As a Scientific Business Analyst, you will be at the center of our operations and you'll find that everything we do, every day, is in line with an unwavering commitment to quality.
You will have the important role of developing written end-user requirements for data systems used in various laboratory processes.
These various processes are used to generate high-quality immunoassay data in a regulated Good Laboratory Practices (GLP) setting to support various vaccine programs according to Standard Operating Procedures.
You will perform user testing of data systems and execute test scripts, as needed, prior to validation and deployment in the Production environment.
In addition, you will be part of a dynamic team and should possess a strong work ethic and collaborative spirit.
Your significant experience of applying knowledge of principles, concepts, and practices of the discipline will make you a critical member of the team.
You are proactive in contributing to all team discussions and creating an environment of collaboration.
How You Will Achieve It
Perform job responsibilities in compliance with current Good Manufacturing Practices/ Good Laboratory Practice (cGMP/GLP) and all other regulatory agency requirements.
Assist in the development and writing of end-user requirements for data system builds requested by functional assay leads as well as for functional enhancements to existing builds
Assist and perform end-user testing of various data system builds against end-user requirements to ensure that these systems function as intended by the end user
Collaborate with laboratory assay SMEs and RI/IT organizations on data system projects according to Vaccine Research and Development priorities
Attend regular meetings with functional assay leads to review and monitor various data system projects
Review and approve various standard operating procedures (SOPs), as assigned
Maintain compliance with SOP periodic review process
Monitor the SOP review and approval workflows for authored SOPs
Author, review and approve technical reports, as assigned
Maintain strict compliance with departmental and site safety regulations
Stay current on all departmental and corporate training.
Qualifications
Must-Have
Bachelor's Degree in a science-related discipline such as computer science, mathematics, or biological science
Minimum 2 years of assay development experience in a GLP laboratory environment
Minimum 1 year of direct, hands-on experience with information management systems such as LabWare LIMS
Strong verbal and written communication skills
Strong attention to detail and ability to collaborate and
Notes:
Lab work around developing assays= must.
Industry lab experience= must 2+ years.
data systems experience= must. (LIMS, SAS). used it, hands on experience, gathering data, inputting data, etc. NOT coding.
Goal is to gather requirements from end users to then build data systems around their assays. As end users perform assays, this system will will gather and analyze data in a more streamlined way and then allow end users to pull data.
NOT developing the systems. will pass the information gathered off to developers.
will do testing, point out any bugs, work through any issues and ensure system is working as planned.
5 -15 collaborations (developers, independent researchers, etc.)
Hybrid (must follow return to site policy)
onsite will be collaborating with the end users but can also host meetings remote but preferred onsite for face time
user testing can be remote
Interview: phone screen then WebEx with colleagues
Comments:
Candidates must meet Vaccine Research Medical Surveillance Requirements or sign waiver
M-F, 8:30-5 but some flex on times
Hybrid model Pearl River. min 2 days a week onsite. some weeks can be 5 but other weeks 2. need to be flexible
Minimum Education:
bachelors in science related discipline such as computer science, mathematics, or biological science.
Master=okay