Job Title: Data Stewardship and Compliance Business Analyst Location: Summit West, NJ, 07901 - Hybrid or Devens, MA, 01434 - Hybrid Duration: 06 months
Top Skills: • Demonstrated experience in coordinating with cross-functional and site teams to ensure accurate and timely compilation of data. Ability to manage project timelines, prioritize tasks, and handle multiple projects simultaneously. • Demonstrated proficiency in MS Project, PowerPoint, Excel, Word, and Document Managements Systems (Veeva Vault preferred). • Experience in data analysis programs like JMP, R, or Excel. • Background in GXP preferred.
The Data Stewardship and Compliance Business Analyst, Cell Therapy Manufacturing Technology work with a cross-functional team responsible for supporting the production of personalized cell therapy products for global commercial supply. This role will work with peers in the Technical Operations team and site MS&T cell therapy to compile and ready data for regulatory filings and to support validation activities. This position interacts heavily with the Cell Therapy production facilities in Summit, NJ, Bothell, WA and Devens MA to ensure rapid, flawless, compliant, and cost-effective delivery of quality products. The role will benefit from a strong understanding of working within quality document systems and managing the on-time document review cycles for a cross functional team. This position is based at either Summit, NJ or Devens MA.
Key Responsibilities
The Data Stewardship and Compliance Business Analyst is closely partnered with the Technical Product Team Lead and Stewards to enable effective execution of strategy and plans. • Compile and efficiently manage process data from various data owners to enable effective data management. • Coordinate with cross-functional and site teams to ensure accurate and timely compilation of data. • Collect data from multiple sources and conduct data verification processes to ensure accuracy and integrity. • Lead quality system document review and routing. • Follow up with reviewers and approvers in client's document system to ensure timely completion of document reviews and approvals. • Manage project timelines and scenario planning to ensure timely completion of tasks. • Handle all meeting logistics, including the creation of agendas, meeting minutes, and follow up actions.
Experience / Qualifications: • Bachelor's degree in engineering or relevant scientific discipline with at least 2 years of relevant experience. • Highly motivated self-starter that works well both in teams as well as independently. • Strong experience in compiling and managing process data from various sources. Proficiency in data analysis, data verification, and ensuring data accuracy and integrity. • Background in GXP preferred. • Demonstrated experience in coordinating with cross-functional and site teams to ensure accurate and timely compilation of data. Ability to manage project timelines, prioritize tasks, and handle multiple projects simultaneously. • Strong organizational skills, ability to multi-task and work in a dynamic, fast paced environment. • Excellent communication skills to effectively coordinate with various stakeholders, including data owners, cross-functional teams, and reviewers/approvers. Strong collaboration skills to work in a team-oriented environment. • Demonstrated proficiency in MS Project, PowerPoint, Excel, Word, and Document Managements Systems (Veeva Vault preferred). • Experience in data analysis programs like JMP, R, or Excel. • Demonstrated ability to build relationships, influence, negotiate, and drive organizational engagement.
About Us: Established in 2004, SPECTRAFORCE® is one of the largest and fastest-growing diversity-owned staffing firms in the US. The growth of our company is a direct result of our global client service delivery model that is powered by our state-of-the-art A.I. proprietary talent acquisition platform, robust ISO 9001:2015/ISO 27001 certified processes, and strong and passionate client engaged teams. We have built our business by providing talent and project-based solutions, including Contingent, Permanent, and Statement of Work (SOW) services to over 140 clients in the US, Canada, Puerto Rico, Costa Rica, and India. Key industries that we service include Technology, Financial Services, Life Sciences, Healthcare, Telecom, Retail, Utilities and Transportation. SPECTRAFORCE is built on a concept of “human connection,” defined by our branding attitude of NEWJOBPHORIA®, which is the excitement of bringing joy and freedom to the work lifestyle so our people and clients can reach their highest potential. Learn more at: http://www.spectraforce.com
Benefits: SPECTRAFORCE offers ACA compliant health benefits as well as dental, vision, accident, critical illness, voluntary life, and hospital indemnity insurances to eligible employees. Additional benefits offered to eligible employees include commuter benefits, 401K plan with matching, and a referral bonus program. SPECTRAFORCE provides unpaid leave as well as paid sick leave when required by law.
Equal Opportunity Employer: SPECTRAFORCE is an equal opportunity employer and does not discriminate against any employee or applicant for employment because of race, religion, color, sex, national origin, age, sexual orientation, gender identity, genetic information, disability or veteran status, or any other category protected by applicable federal, state, or local laws. Please contact Human Resources at LOA@spectraforce.com if you require reasonable accommodation. At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $50.00/hr.
