Data Specialist Jobs in Boston, MA

Title: MSAT Data & Process Specialist

Location: Boston, MA

Job Summary

The MSAT Lifecycle Management Data & Process Specialist supports the management, validation, analysis, and delivery of commercial manufacturing data throughout the product lifecycle. This role works closely with MSAT and cross-functional teams to maintain data integrity, support regulated lifecycle management activities, and ensure accurate, consistent, and compliant execution of established data processes. The ideal candidate is detail-oriented, organized, comfortable working with scientific and manufacturing data, and able to consistently follow defined processes within a regulated environment.

Key Responsibilities

Manufacturing Data Management & Stewardship

- Enter, review, verify, and approve manufacturing data received from global internal and external manufacturing networks within validated databases and systems.
- Ensure manufacturing data is complete, accurate, consistent, traceable, and maintained in accordance with established procedures.
- Prepare and distribute validated datasets and manufacturing process information for regulatory submissions, agency responses, technical studies, and cross-functional requests.
- Maintain accurate historical manufacturing datasets to support lifecycle management and ongoing process monitoring activities.

Lifecycle Management & Regulatory Support

- Support Continuous Process Verification (CPV) activities through accurate collection, management, verification, and reporting of global manufacturing data.
- Support Annual Product Quality Review (APQR) activities by maintaining reliable manufacturing datasets and providing required data and information.
- Perform and support Data Verification (DV) activities associated with regulatory submissions, agency information requests, technical documentation, and lifecycle management activities.
- Perform data management activities in accordance with GMP/cGMP requirements, data integrity principles, standard operating procedures, and internal controls.
- Assist with maintaining documentation and records required to demonstrate data accuracy, traceability, and compliance.

Process Monitoring & Investigation Support

- Review manufacturing datasets to identify trends, discrepancies, missing information, and potential data-quality concerns.
- Support the identification and review of Out-of-Trend (OOT) and Out-of-Specification (OOS) results and other potential process or data issues.
- Assist MSAT teams with process trending, technical investigations, CPV activities, and cross-functional manufacturing data reviews.
- Generate metrics, summaries, dashboards, and data-driven reports to support compliance, process monitoring, and business decision-making.
- Perform structured and repetitive data-management activities with a high degree of accuracy, consistency, and attention to detail.

Digital Tools & Data Systems

- Utilize Microsoft applications, databases, data-management systems, Power BI, workflow tools, automation platforms, and other digital technologies supporting data management and reporting.
- Learn and effectively use new systems, software applications, and internal digital platforms.
- Support continuous-improvement and digital-transformation initiatives within MSAT.
- Explore and appropriately utilize automation, AI-enabled tools, and other emerging technologies to improve efficiency and data-management processes.

Cross-Functional Collaboration & Operational Support

- Collaborate with MSAT, manufacturing, quality, regulatory, and other cross-functional teams to support lifecycle-management activities.
- Manage multiple priorities while consistently meeting established timelines and quality expectations.
- Work effectively in a fast-paced, team-oriented environment with changing priorities.
- Follow established procedures and work instructions consistently within a regulated environment.
- Take on additional responsibilities and learn new processes as business and departmental needs evolve.

Education & Experience

- Bachelor’s degree in Life Sciences, Biochemistry, Chemistry, Process Chemistry, Manufacturing, Manufacturing Sciences & Technology (MSAT), or a related scientific discipline.
- Engineering degrees with a Life Sciences or related scientific concentration may also be considered.
- 0–2 years of relevant professional experience, including internships, co-ops, academic projects, or industry experience.
- Recent graduates with relevant academic or laboratory experience are encouraged to apply.
- Exposure to a GMP/cGMP-regulated pharmaceutical, biotechnology, medical device, or similarly regulated environment is preferred.
- Experience working with data systems or performing data entry, verification, management, analysis, or reporting activities.
- Basic understanding of statistics and the ability to work with scientific, technical, or manufacturing data.

Preferred Qualifications

- Basic knowledge of Python, SQL, C++, or other programming/coding concepts.
- Exposure to Power BI, Excel, databases, data visualization, or reporting tools.
- Familiarity with GMP/cGMP, data integrity, manufacturing processes, or quality systems.
- Academic or internship experience involving scientific data analysis, manufacturing data, process monitoring, or data management.

Required Skills

- Exceptional attention to detail and ability to maintain accuracy while performing structured and repetitive activities.
- Strong organizational and time-management skills.
- Ability to follow established procedures, work instructions, and regulated processes consistently.
- Comfortable working with digital systems and learning new software and internal platforms.
- Ability to manage multiple tasks and changing priorities in a fast-paced environment.
- Strong analytical and problem-solving abilities.
- Effective written and verbal communication skills.
- Strong collaboration and teamwork skills.
- Willingness to learn new technologies, processes, and responsibilities.
- Ability to handle confidential and regulated information appropriately.