R&D Quality Specialist Document Control

Band

Job Description Summary

Job Description

Key Responsibilities:

• Manage Doc Control Room and related activities such as support issuance review and approval of batch records and related documents including but not limited to logbooks labels Tech Docs etc.
• Write and review GMP-relevant deliverables and/or related tools as per area of responsibility in order to ensure compliance with cGMP and project quality deliverables.
• Support site audits and other projects as required.
• Review / Approval of Change Controls QE CAPA and actions.
• Review / Approval of documents in document management systems such as ESOPS D2 CONDOR SUBWAY.

Essential Requirements:

• BS degree in Scientific discipline or engineering related field or equivalent.
• At least 3 years of experience in cGMP that includes good documentation practices
• Communication skills to sufficiently address GMP and logistic related questions with line unit experts.
• Knowledge of cGMPs and understanding of the concepts of GDP and Data Integrity.
• Good organizational skills.
• Ability to communicate effectively with cross-functional groups in various aspects of company operations.
• Experience in Cell & Gene Therapy strongly preferred

Novartis Compensation and Benefit Summary: The salary for this position is expected to range between $77000 and $143000/year. The final salary offered is determined based on factors like but not limited to relevant skills and experience and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors. Your compensation will include a performance-based cash incentive and depending on the level of the role eligibility to be considered for annual equity awards.

US-based eligible employees will receive a comprehensive benefits package that includes health life and disability benefits a 401(k) with company contribution and match and a variety of other addition employees are eligible for a generous time off package including vacation personal days holidays and other leaves.

EEO Statement:

The Novartis Group of Companies are Equal Opportunity Employers. 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 strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.

Accessibility and reasonable accommodations

The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If because of a medical condition or disability you need a reasonable accommodation for any part of the application process or in order to perform the essential functions of a position please send an e-mail to call 1 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Range

Skills Desired