Responsibilities:
The Document Control Specialist will provide assistance for the Document Control program, including day-to-day document processing, document archiving, and supporting continuous improvement of document and user databases.
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Review GxP documents for completeness, consistency, formatting, and adherence to company guidelines
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Facilitate and support document reviews, consolidate comments and redlines, initiate and track document review/approval workflows
- Manage periodic reviews of controlled documents
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Work cross-functionally to manage and complete document revisions
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Maintain Quality records, including training documentation, audit documentation, etc.
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Educate new and existing employees about document control and Good Documentation Practice requirements
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Provide support and guidance to cross-functional colleagues with documentation needs
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Provide technical assistance on the document management and training systems to end users
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Assist with the development of a Quality document archive
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Provide backup support for the GxP Training Program
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Inspection Team member for regulatory agency/health authority inspections
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Assist with internal and partner audits
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Assist with archiving paper documentation in Karyopharm’s document archive (e.g., scanning files, logging in documents, etc.)
Qualifications:
- BA or AD or equivalent work experience preferred
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2+ years document control experience preferred
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Excellent technical skills required; candidate must be comfortable working in and collaborating with users across multiple computer systems
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Strong writing and proofreading skills
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Experience with document formatting in Microsoft Word
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Strong organizational skills, including the ability to execute ongoing multi-step processes
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Ability to multitask and work efficiently and independently with all levels of the organization
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Exposure to GxP regulations required
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Experience using Adobe Acrobat Pro, Excel, and Microsoft Visio required
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Veeva Vault Quality experience strongly preferred
Overview:
At Karyopharm, we live and demonstrate our ICARE values every day!
We are passionately driven in our mission to positively impact patients’ lives and defeat cancer! This is personal, and we approach every challenge fiercely and tenaciously, but with enthusiasm, empathy, and passion. The work we do is both inspiring and life-changing. It requires the most diverse, the most unique, and the most authentic team in the industry. We are 400+ cancer driven conquerors, across the globe, with a strong sense of our values and our purpose. We are innovators, disrupters, and collaborators, and we challenge the norm and do things differently. At Karyopharm you will have the opportunity to do well by doing good, while learning and growing along the way. We invite you to join us and make your own personal contribution to our mission!
What We Offer:
In addition to our exciting, supportive, and intellectually challenging global workspaces(s), Karyopharmers enjoy a comprehensive and generous benefits package (active on day one) that makes them more productive and contributes directly to the development of their professional skills.
A fun, collaborative, work environment-
A culture of employee engagement, diversity, and inclusion
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Competitive salary, bonus, and generous equity offerings (RSU’s at time of offer and annual awards) – we are partners in prosperity!
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Peace of mind through best in class medical (deducible paid by KPTI), dental, vision, disability, and life insurance, parental leave, a matching 401k program (immediate vesting), and tuition reimbursement.
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Generous PTO and Holidays – we encourage you to recharge and spend time with family and friends.
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Ample opportunities to learn and take on new responsibilities in a fast-paced, and patient focused company. (tuition reimbursement, management development programs, and a variety of reward and recognition programs)
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Cell phone allowance
In the U.S., the salary range for this position is $73,000 to $136,000 per year, which factors in various geographic regions. The base pay actually offered will take into account internal equity and also may vary depending on the candidate’s geographic region, job-related knowledge, skills, and experience among other factors
- Karyopharm requires all employees to be fully vaccinated against the Covid19 virus at the time of employment
This position is eligible for hybrid working arrangement (may work hybrid on-site/virtual as required by hiring manager).
ABOUT KARYOPHARM
WE ARE COMMITTED TO DE&I
