Data Stewardship and Compliance Business Analyst - Summit, United States - Synectics Inc

Synectics Inc Summit, United States

4 weeks ago

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Description

Job Description

Job Description:

The Data Stewardship and Compliance Business Analyst within Cell Therapy Manufacturing Technology collaborates with a diverse team to support the production of personalized cell therapy products for global supply.
This role involves working with colleagues in the Technical Operations team and site MS&T cell therapy to prepare data for regulatory filings and validation activities.
The position interacts extensively with Cell Therapy production facilities to ensure efficient delivery of quality products that meet compliance standards.
The Data Stewardship and Compliance Business Analyst closely partners with the Technical Product Team Lead and Stewards to facilitate the execution of strategy and plans.
Compile and manage process data from various sources to enhance data management efficiency.
Coordinate with cross-functional and site teams to ensure accurate and timely compilation of data.
Gather data from multiple sources and conduct verification processes to maintain data accuracy and integrity.
Oversee quality system document review and routing.
Follow up on document reviews and approvals to ensure timely completion.
Manage project timelines and scenario planning for task completion.
Handle meeting logistics, including agenda creation, meeting minutes, and follow-up actions.

Qualifications:

Bachelor's degree in engineering or relevant scientific field with a minimum of 2 years of experience.
Demonstrated ability to coordinate with cross-functional and site teams for timely data compilation.
Proficient in managing project timelines, prioritizing tasks, and handling multiple projects concurrently.
Proficiency in MS Project, PowerPoint, Excel, Word, and Document Management Systems (Veeva Vault preferred).
Experience with data analysis tools such as JMP, R, or Excel.
Background in GXP preferred.
Motivated self-starter with strong organizational and data management skills.
Excellent communication skills for effective coordination with stakeholders.
Strong collaboration abilities for team-oriented environments.
Proven capability to build relationships, influence, negotiate, and engage with organizations.
Understanding of quality document systems and managing document review cycles for cross-functional teams.

Benefits:

Healthcare Insurance: Synectics provides healthcare coverage through BlueCross BlueShield of Illinois for eligible employees and their dependents. Premiums are subsidized by Synectics.

Dental Insurance: Dental coverage through MetLife for eligible employees and dependents.

Vision Insurance: Vision insurance through VSP for eligible employees.

401(k) Plan: Investment Savings Retirement Plan offered to all employees aged 21 and above.

Technical Certification Bonus: Bonus of up to $500 for approved professional certification. Awarded after successful completion of certification and subject to conditions.

Synectics is an equal opportunity employer.

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