Senior Document Control Specialist
AAA Statement Advanced Accelerator Applications, a Novartis company, is an innovative medicines company focused on the development of products for targeted radioligand therapy and precision radioligand imaging. We are committed to transforming patients' lives by leading innovation in nuclear medicine.
AAA offers professionals the opportunity to face new challenges and pursue a career in a fast growing, technology driven healthcare company. We are passionate about improving patient health by leading innovation in nuclear medicine. We are looking for people who share our commitment to help us achieve this goal. Advanced Accelerator Applications is an Equal Opportunity Employer (EOE). Job Description 766 million lives were touched by Novartis medicines in 2021, and while we're proud of this, we know there is so much more we could do to help improve and extend people's lives. We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.
We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world's toughest medical challenges. Because the greatest risk in life, is the risk of never trying!
Imagine what you could do here at Novartis!
The Senior Document Control Specialist is responsible for the control, management and retention of GxP electronic and paper records at the AAA Indianapolis site ensuring compliance to quality objectives and regulatory requirements..
Your responsibilities include, but are not limited to:
* Provide GxP document control support for operations, engineering, supply chain, quality and other departments as required.
* Ensure site documentation fully adhere to cGMP, including data integrity. Ensure timely escalation to management of all applicable incidents.
* Track and manage document retention for both onsite and offsite documentation.
* Manages the preparation, routing, review, approval, distribution, and archival of new and revised controlled/managed documents.
* Reviews documents submitted to ensure the correct use of templates, correctly entered metadata and document types.
* Performs advanced word processing and assists personnel in resolving document format issues.
* Quality focused and works closely with SMEs to execute workflows and business processes that align with best practices.
* Provides guidance and advice on approved procedures, standardization and requirements associated with the document management system.
The pay range for this position at commencement of employment is expected to be between $80,000.00 and $120,000.00 per year; however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an "at-will position" and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.
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?wmode=transparent style='max-width:100%;width:400px;height:300px' type='text/html' frameborder='0'> EEO Statement The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential. Minimum requirements 4+ years of experience in pharmaceutical-based GMP manufacturing operations.
2+ years of experience with Electronic Document Management Systems, specifically related to GMP document control.
* Proficient with the Microsoft Office suite (ie, Word, Excel, Visio, PowerPoint, etc.) and Adobe.
* Works under minimal supervision; requires a high level of independence.
* Ability to be impactful and efficient.
* Excellent knowledge of understanding of applicable GxP regulations, including FDA regulations (21 CFR Parts 211, 212) and ICH
* Knowledge of IT Applications & tools
* Quality Assurance
* Quality Control (QC) Testing Business Unit ADVANCED ACCELERATOR APPLICATIONS Work Location Indianapolis, IN Company/Legal Entity AAA USA Inc.
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Novartis Group Companies
parental leave, paid time off, sick time, 401(k)
May 31, 2023