Description
Verista’s 500 experts team up with the world’s most recognizable brands in the life science industry to solve their business needs. The nature of our business is to empower growth and innovation within the scientific community and to help researchers, organizations, and companies solve some of the world’s most pressing healthcare challenges. Verista provides innovative solutions and services that empower informed decision-making and are the result of our significant investment in our people and our capabilities.
Our ability to grow is driven by world-class people who thrive in a team environment and share our mission to enable life sciences clients to improve lives. Our talented and dedicated professionals are committed to making an impact every day.
Company Culture Guidelines & Values:
- We empower and support our colleagues
- We commit to client success at every turn
- We have the courage to do the right thing
- We encourage an inclusive environment where our colleagues feel respected, engaged, and challenged.
- We constantly acquire new skills and learn from our experiences to enhance our collective expertise
The Business System Specialist will be responsible for the creation and revision, as well as review and approval of LIMS master data within the LabVantage Laboratory Information Management System (LIMS) implemented at the Vertex Cell and Gene Therapy sites (LC1, Cambridge and VCGT at VMC site) for the GxP LIMS system. This position will be responsible for providing end-user support for all MFG, QC, QA, Supply Chain and analytical groups as well as compliance with global Vertex internal policies and procedures. The specialist is also responsible for LES worksheets design configuration and delivery. The specialist is responsible for supporting the EMUM program from LIMS perspective. The Specialist will drive the LIMS master data process from the very beginning to the end including change control management, master data verification, data migration etc.
Business System Specialist Responsibilities:
- Work with site leaders to identify, capture and update all master data for each site within VCGT (Cambridge, LC1 and VMC site) for GxP operations
- Work with a project team to identify, capture and update all master data for PD operations within VCGT (Cambridge, LC1 and VCGT at VMC site)
- Leads QC, QA and MFG departments in the build and/or revision, review and approval of LIMS master data, including but not limited to products, sampling plan, specifications, methods, sample points, and LES templates in LIMS, per global and local LIMS procedures
- First-line support for end-user LIMS LES templates and data entry issues, COA generation, EMUM data module etc.
- Support in the development, implementation, enhancement of the overall process for requesting, creating/revising, and reviewing master data at the VCGT Cambridge, LC1 and VCGT at VMC site facilities
- Assist in the development and implementation of a site process for the scheduling and status tracking of all sites LIMS Master Data, including needs for Raw Material, Intermediate, Drug Substance and Finished Product, EM/UM and Stability testing
- Work with the site LIMS Administrator and Business Owner to maintain site and global requirements of LIMS
- Participate in the development and/or revision of VCGT Standard Operating Procedures
- Support LIMS System/Process auditing to ensure data is current
- Assist with training for end users to use the system
- Collect digital platform business requirements, user story and use cases, support user acceptance testing
- Act as digital platform superuser and coordinate with business subject-matter experts from different levels for business needs.
- Responsible for training Jr. specialist with system knowledge and drive through technical difficulty in partnering with the technical lead
- Responsible to master data module maintenance and perform system master data related impact assessment and taking change actions
- Build instruments and consumables including critical reagents master data in LIMS system
Requirements:
- Bachelor's degree in technology discipline or equivalent in technology or science discipline or equivalent. Combined degrees and/or experience in fields of biology, data analysis, Statistics and data science is preferred
- Typically requires 2- 4 years relevant experience in the Life Sciences, or the equivalent combination of education and experience
- Familiarity with cell and gene therapy methodologies such as Cell Viability, Flow cytometry and other cell functional assays
- Knowledge of LabVantage system master data and system usage functionality, requires at least 3 years of experience
- Knowledge of regulated systems – general level of understanding of systems validation
- Capable and comfortable multi-tasking between concurrent projects
- Experience of GxP laboratory and Manufacturing process, and non-GxP research laboratory analytical development and product processes development
- Must demonstrate ability to work in a team environment and willingness to assume additional or new responsibilities readily
- Must detail oriented pay close attention and notice minor details
- Effective communication skills, both verbal and written. Knowledge of regulated systems – general level of understanding of systems validation
- Skills of Master Data management in LIMS Systems, together with Data Analysis/Data Management
- Capable and comfortable multi-tasking between concurrent projects
For US geography, the salary range for this position is shown below. The actual salary is dependent upon a variety of job-related factors such as professional background, training, work experience, location, business needs, market demand, and competitive market practice. Therefore, in some circumstances, the actual salary could fall outside of this expected range. This salary range is subject to change and may be modified in the future.
*Verista is an equal opportunity employer.
Benefits
Why Choose Verista?
- High growth potential and fast-paced organization with a people-focused culture
- Competitive pay plus performance-based incentive programs
- Company-paid Life, Short-Term, and Long-Term Disability Insurance.
- Medical, Dental & Vision insurances
- FSA, DCARE, Commuter Benefits
- Supplemental Life, Hospital, Critical Illness and Legal Insurance
- Health Savings Account
- 401(k) Retirement Plan (Employer Matching benefit)
- Paid Time Off (Rollover Option) and Holidays
- As Needed Sick Time
- Tuition Reimbursement
- Team Social Activities (We have fun!)
- Employee Recognition
- Employee Referral Program
- Paid Parental Leave and Bereavement
Verista collects and processes personal data in accordance with applicable data protection laws. If you are a California Job Applicant, see the privacy notice for further details.
For more information about our company, please visit us at Verista.com
Top Skills
What We Do
Verista is a leading business and technology consultancy firm that provides systems, compliance, validation and quality solutions to life science companies - enabling them to improve health and improve lives. We help clients solve their most critical and complex challenges across the GxP lifecycle, from preclinical and clinical to commercialization, manufacturing and distribution – bringing together decades of knowledge, the most advanced engagement platforms and transformative technologies. This allows clients to benefit from the ease, efficiency and trust that results from working with one partner who excels across specialties. Verista’s clients trust the company’s 650+ experts to deliver consistent, safe, and high-quality results across the product development lifecycle. Verista is based in Fishers, Indiana, Wayne, Pennsylvania, Westford, Massachusetts, and San Mateo, California. For more information, visit www.verista.com
