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Novartis Hiring for GMP and Data Integrity Officer (Wednesday – Saturday) job in Millburn Full Time
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).
236 million lives were touched by Novartis medicines in 2022, 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 Quality Operations GMP and Data Integrity Officer is responsible for first level, hands on, day-to-day cGMP facilitator role for all site related GMP activities. They interact directly with site staff, who are performing the daily operational functions in support of their effort to produce quality products.
Your responsibilities include, but are not limited to:
• Provides oversight to operations on production shop floor, supporting operators and support staff as needed to identify and address product quality and compliance issues as they arise.
• Support deviations and investigations as related to production and/or GDP related issues
• Review and audit production batch records, and related documentation, to ensure adherence to Novartis policies, SOPs, and cGMP requirements.
• Support Production Management in creating a GMP/GDP culture on the shopfloor
• Oversight of aseptic operations including but not limited to ViMOS, EM program, walkthrough program, etc.
• Triaging of issues, initiate deviation reports into the system and partner with PU, and other areas for issue resolution.
• Actively participate in process improvement initiatives aiming for Right First Time (RFT) on documentation and deviation reduction in collaboration with Process Expert teams.
• Present systems and provide documentation for self-inspections and external audits.
• Interact with FDA, partner, and supplier auditors/inspectors, as needed.
• Continuously improve data integrity knowledge base and understanding: Identify training needs and ensure availability of appropriate and functionally relevant training materials; where training does not exist, facilitate creation of material and delivery of training.
Note: This position will be expected to work 4 x10 shift, Wednesday to Saturday.
The pay range for this position at commencement of employment is expected to be between $88,000.00 and $132,000.00 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.What you’ll bring to the role:
Bachelor’s Degree in life sciences, Engineering, Chemistry, Pharmaceuticals
• Minimum of 2 years of experience in a pharmaceutical environment.
• Experience in Deviation Management and batch disposition required
• Strong knowledge and understanding of cGMPs, keeping up to date with current industry
issues and changing regulations.
• Excellent oral and written communication skills required.
• Demonstrate leadership ability and excellent interpersonal skills; strategic and tactical skills.
• Ability to work under minimal direction, independently or as part of a team if necessary. Strives for simplicity and clarity.
• 1QEM, MES, LIMS knowledge preferred
• Able to translate high level concepts into tangible, site or function relevant action plans.
• Good skills in identifying issues and solving problems; critical thinking skills.
• Good overall technical knowledge in aseptic processing/manufacturing (i.e., processes, equipment, products, validation, QC, manufacturing).
• Comfortable to influence individuals at all levels within the organization
Why Advanced Accelerator Applications?
Thousands of people die of cancer around the world every day. At Advanced Accelerator Applications, a Novartis company, our mission is to transform lives through radioligand therapy in nuclear medicine to fight several leading types of cancer. How will we continue to be on the cutting edge of medicine? We believe new groundbreaking 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!
Commitment to Diversity & Inclusion:
Novartis embraces diversity, equal opportunity, and inclusion. 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.
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 [email protected] call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network.
