MSAT Lifecycle Management Data & Process Specialist

Intellectt INC

Position: MSAT Lifecycle Management Data & Process Specialist

Location: Boston, MA Hybrid (2 3 days onsite)

Duration: 2+ Years

Job Summary:
This role supports the management, validation, and delivery of commercial manufacturing data across the product lifecycle. The specialist will work with MSAT and cross-functional teams to maintain data integrity, support regulated lifecycle management activities, and execute established data processes accurately.

Key Responsibilities:

Enter, review, verify, and approve manufacturing data from global internal and external manufacturing networks using validated databases.
Prepare validated datasets and manufacturing process information for regulatory submissions, agency responses, technical studies, and cross-functional requests.
Support Continuous Process Verification (CPV) and Annual Product Quality Review (APQR) reporting.
Perform Data Verification (DV) for regulatory submissions, agency requests, and technical documentation.
Maintain data in compliance with GMP/cGMP, data integrity standards, procedures, and internal controls .
Review manufacturing data for trends, discrepancies, OOT , and OOS results.
Support process trending, technical investigations, CPV activities, and cross-functional data reviews.
Generate metrics, summaries, and reports for compliance and process monitoring.
Utilize Microsoft applications, data systems, Power BI , and workflow/automation tools.
Support digital improvement initiatives and perform structured data activities with a high level of accuracy.

Qualifications:

Bachelor's degree in Life Sciences, Biochemistry, Process Chemistry, Manufacturing, MSAT , or a related scientific discipline.
Engineering degrees with a Life Sciences concentration may also be considered.
2 years of relevant professional, internship, co-op, or industry experience.
Recent graduates with relevant academic experience may be considered.
Exposure to GMP or other regulated environments .
Experience with data entry, verification, management, analysis, or reporting.
General understanding of statistics and scientific, technical, or manufacturing data.
Strong attention to detail, organization, communication, and ability to follow established procedures.
Comfortable working with Microsoft applications and learning new digital systems.
Basic knowledge of Python, SQL, C++, or similar programming languages is a plus.

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Vacancy posted 1 day ago

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