Company Overview
Rangam is a global, innovative, total talent management firm with a mission to accelerate meaningful employment for everyone. With over 25 years of experience, we have established ourselves as a minority-, woman-, and disability-owned company dedicated to promoting sustainable and inclusive talent programs within our communities and among employers. Our comprehensive approach to talent management is guided by our core values and operates under the Entrepreneurial Operating System (EOS) model. At Rangam, we specialize in attracting and retaining talent on a global scale, focusing on various sectors such as IT, Engineering, Scientific, Clinical, Healthcare, Administrative, Finance, and Business Professional. Some of the notable awards and recognition we have received include: • 2024 EcoVadis Commited Award • 2024 VETS Indexes Employer Award • 2024 DE&I Influencers • 2024 SIA Staffing 100 North America • 2023 VETS Indexes Employer Award • 2023 Disability:IN Supplier of the Year Award • 2023 The Beeline Talent Innovation of the Year Award • 2022 Fastest Growing Staffing Firms • 2022 SIA Global Power 150 Women in Staffing • 2022 Fastest Growing Diverse Supplier • 2021 Rangam Featured in Innovate New Jersey • 2021 DE&I Influencers by SIA • 2020 NJBIA Awards for Excellence
About the job
Works collaboratively with Process Engineers and Statisticians in Global Manufacturing Sciences and Technology (GMSAT), Statistical Sciences & Analytics (SS&A) team to meet project deliverables and timelines to author and approve Continued Process Verification (CPV) related reports, such as Process Monitoring Reports (PMR) and Annual Product Reviews (APR).
Requirements and Preferred Qualifications:
- BS degree with 5 years or MS degree with 3 years of technical experience in biologics / biopharma, high-tech industry
- BS or MS degree in Data Analytics, Data Science, Applied Statistics or Applied Math, preferred
- Proficient in SQL, SAS or equivalent for data extraction and transcription
- Proficient in JMP, SAS or equivalent for statistical analyses and familiar with Statistical Quality Control techniques, e.g., SPC and Process Capability.
- Knowledge of python code for report generation.
- Proficient in Microsoft Word and Excel
- Exceptional attention to detail with the ability to meet aggressive deadlines
- Good communication and documentation skills, ability to network and interact with manufacturing sites in different time zones
- Knowledge of data management and ability to manage project and prioritize multiple projects
- Familiarity with a Quality Management System () and how it is used in biotech
Summary:
- Performs Data Verification requirements per Client’s Standard Operating Procedures (SOP), e.g., reproduces all CPV statistical output using JMP scripts, reviews documents for data and information accuracy, notifies author of errors and ensures corrections are made prior to approval and completes sign offs in QMS.
- Assists with report authoring by populating graphs, tables and attachments in Word templates and identifying deviations using QMS.
- Extracts and transforms data from excel or databases, as needed.
- Attends and participates in regular meetings to review and track report progress.
- Assists with the preparations for bi-monthly Process Monitoring Tier 4 meetings, attends meetings and takes meeting minutes.
- Must be able to effectively communicate and possess good problem solving as well as people/project leadership skills.
Project Work:
Report Authoring:
- PMRs: pre-populate tables (including deviation tables) and graphs
- Control Limits: Manage and prepare data, compute and propose statistical limits and assist with report authoring
Report Verification:
- PMRs: raw data, figure and table formats, re-run all charts, check control limits, tables, statistics summaries and deviations against original data sources and metadata files.
- APRs: raw data, figure and table formats, re-run all charts, check control limits, tables, statistics summaries and deviations against original data sources and metadata files.
- Control limits: verify analytics approaches uses, re-run all analysis, verify updated limits.
Tier 4 Meetings:
- Take minutes
- Cross-site comparison prep: prepare data, generate outputs from JMP scripts and update the slide deck.