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Quality Assurance Document Control Specialist
2 months ago
Genezen is seeking a highly skilled Quality Assurance Document Control Associate II to join our team. As a key member of our Document Control team, you will play a critical role in ensuring the accuracy and integrity of our documents.
Key Responsibilities- Document Administration: Perform document administrator functions within our Electronic Document Management System.
- Document Formatting: Format documents in accordance with approved templates and procedures.
- Document Issuance and Verification: Issue and verify controlled documents and unique identifiers, including lot numbers and labels.
- Document Archiving and Tracking: Perform archival, scanning, and tracking of physical documents.
- Policy and Procedure Development: Revise and develop policies and procedures for the document control system in support of our Quality Management System as needed.
- Document Submission and Retrieval: Submit and request documents to and from off-site storage.
- Training and Support: Provide support and training as needed for the use of the EDMS.
- Inspection Support: Provide support for inspections, including tracking inspection requests, document retrieval, and generation of official copies.
- Document Expiration and Review: Track documents relative to expiration and review periods.
- Training and Development: Maintain training on documents relative to job functions.
- Experience: 2-4 years of experience in Document Control or a related area.
- Education: Bachelor's degree or equivalent experience.
- Skills: Proficient with Microsoft Word, Excel, Outlook, and Adobe Acrobat. Experience with Veeva preferred.
- Personal Qualities: Adaptability, attention to detail, strong communication and customer service skills, organizational skills, time management, self-directed, and motivated.
Genezen is a leading biotechnology company dedicated to developing innovative treatments for rare genetic diseases. We are committed to scientific excellence, staying current with industry developments, making data-driven decisions, and pursuing innovation to advance healthcare.
Benefits- Paid vacation days, amount based on tenure.
- Paid sick time.
- 9 observed holidays + 1 floating holiday + 1 volunteer day.
- 401(k) plan with company match up to 6% of salary, vested immediately.
- Share Appreciation Rights.
- Choice of several healthcare plans.
- FSA and HSA programs.
- Dental and vision care.
- Employer-paid basic term life/personal accident insurance.
- Voluntary disability, universal life/personal accident insurance.
- Accidental Death and Dismemberment (AD&D) Insurance.
