MSAT Lifecycle Management Data & Process Specialist (Contract)
The MSAT Lifecycle Management Data & Process Specialist manages and validates manufacturing data throughout the product lifecycle, ensuring data integrity and regulatory compliance. This role supports cross-functional teams with data verification, process monitoring, and digital innovation initiatives in a regulated manufacturing environment, contributing to quality assurance and continuous improvement efforts.
About Careertakes
👉 Important disclosure: Careertakes is a third-party recruiting platform supporting this hiring process. If selected, you will be employed directly by our client, Scientific & QA.
Applicants for this role may also receive access to additional matched opportunities through the Careertakes platform.
What You’ll Do
The MSAT Lifecycle Management Data & Process Specialist will support the management, validation, and delivery of commercial manufacturing data across the product lifecycle. You'll partner with MSAT and cross‑functional teams to preserve data integrity, support regulated lifecycle management activities, and ensure consistent execution of established data processes.
- Enter, review, verify, and approve manufacturing data from global internal and external manufacturing networks in validated databases.
- Prepare validated datasets and manufacturing process information to support regulatory submissions, agency responses, technical studies, and cross‑functional requests.
- Support Continuous Process Verification (CPV) and Annual Product Quality Review (APQR) reporting by maintaining complete historical datasets.
- Execute and support Data Verification (DV) activities related to regulatory submissions and agency information requests.
- Review datasets to identify trends, discrepancies, Out‑of‑Trend (OOT) or Out‑of‑Specification (OOS) results and escalate potential process concerns.
- Support MSAT process trending, technical investigations, CPV activities, and cross‑functional data reviews.
- Generate metrics, summaries, and reports to support compliance and departmental decision‑making.
- Consistently execute structured and repetitive data processes with high accuracy and attention to detail.
- Work with Microsoft tools, data systems, Power BI, automation/workflow tools, and other digital platforms to support data management and reporting.
- Support continuous improvement and digital initiatives, including leveraging automation and AI‑based tools where appropriate.
Qualifications
Education & experience
- Bachelor’s degree in Life Sciences, Biochemistry, Process Chemistry, Manufacturing, Manufacturing Sciences & Technology (MSAT), or a related scientific discipline. Engineering degrees with a Life Sciences concentration may be considered.
- 0–2 years of relevant professional, internship, or co‑op experience; recent graduates with relevant academic experience are encouraged to apply.
- Experience or exposure to a GMP/cGMP regulated environment preferred.
- Experience working with data systems or performing data entry, verification, management, analysis, or reporting activities.
- Basic familiarity with Python, SQL, C++, or programming concepts is beneficial.
- General understanding of statistics and comfort working with scientific or manufacturing data.
Required knowledge & skills
- Strong attention to detail and the ability to maintain accuracy while performing structured, repetitive work.
- Comfortable with digital systems and Microsoft applications; ability to learn new internal platforms quickly.
- Strong organizational and time‑management skills; able to manage a meaningful workload in a fast‑paced environment.
- Ability to follow established procedures and internal controls within regulated processes.
- Good communication and collaboration skills; eagerness to learn and take on new responsibilities.
Contract & Compensation
- Contract length: 6 months, with the possibility of extension.
- Compensation: $44.00/hr – $48.00/hr (hourly).
- Schedule: Monday–Friday, Hybrid.
- Employment type: Contract (full time). This is a temporary role staffed through a staffing partner and will be on assignment at Confidential Client. The staffing partner will present final terms and benefits where applicable.
- No C2C or third‑party vendor arrangements.
Location & Work Model
- Location: South Boston, MA (hybrid). Candidates must be able to work on‑site as required by the client’s schedule and policies.
Why This Role
- Gain hands‑on experience with manufacturing datasets and regulated lifecycle activities in a Scientific & QA environment.
- Work with cross‑functional teams on CPV, APQR, and regulatory data submissions.
- Opportunity to apply and expand data skills (Power BI, Python/SQL exposure) in a manufacturing/MSAT setting.
Equal Opportunity & Hiring Transparency
Careertakes and our client are Equal Opportunity Employers committed to building a diverse and inclusive workforce. We prohibit discrimination or harassment of any kind. To support a fair and efficient hiring process, AI tools may be used to assist with application review or resume screening. These tools do not replace human decision-making. Final hiring decisions are made by people.
If you have questions about how your data is used, please contact us directly.
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