Overview:
Summary:
The Senior Analyst, Quality Control Compliance is responsible for ensuring adherence to all applicable regulations and standards.
Responsibilities:
Responsibilities:
Manages and investigates deviations and Laboratory Investigation (OOS/OOE/OOT) records, owning the implementation of change controls, reviewing data for accuracy and completeness, and conducting gap assessments to identify areas of non-compliance.- Supports implementation of CAPAs may include authors new/revise Standard Operating Procedures, Protocols / Summary Reports / Plans for QC.
- Owns the implementation of change controls to ensure compliance with regulatory requirements and company policies.
- Reviews data for accuracy and completeness, ensuring that all data is generated, recorded, and reported in compliance with applicable regulations and standards. Must be able to identify and escalate data abnormalities within a timely manner.
- Conducts gap assessments to identify areas of non-compliance and develop plans to address any identified gaps.
- Supports the development and maintenance of compliance-related documentation, including procedures, work instructions, and training materials.
- Participates in regulatory and customer audits, ensuring that all compliance-related activities are properly documented and presented to auditors.
- Supports trend analysis of methods / environmental data / assay controls & standards and draws conclusions.
- Routine testing may be required to support QC operations.
- Supports department risk assessments and participates in audit walk-throughs.
- Supports Quality Control department at QMR by preparing slide deck and presenting laboratory metrics.
- Other related duties as assigned.
Qualifications:
Qualifications:
B.S. degree in life sciences or Engineering with 2 years relevant experience in biopharmaceutical based GMP environment.- Ability to meet required timelines and skilled to escalate issues appropriately when necessary.
- Excellent written and verbal communication skills, with the ability to effectively communicate complex information to both technical and non-technical audiences.
- Experience with data analysis tools and software, such as Excel and statistical software, is a plus. Proficient in Microsoft Word, Excel, Power Point, and other applications.
- Excellent problem-solving skills, with the ability to think critically and make sound decisions.
- Strong attention to detail and the ability to work independently and in a team environment.
- Works on problems of diverse scope where analysis of requires evaluation of identifiable
- Strong Quality mindset and demonstrates good judgment in compliance decisions selecting methods and techniques for obtaining solutions.
- Ability to receive little instruction on day-to-day work for the shift, general instructions on new assignments.
- An understanding of FDA/EMEA regulations.
- Proven track record of success in a similar role.
Why Novartis?
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!
Commitment to Diversity & Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve. Additionally, Novartis Gene Therapies is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, national origin, genetics, disability, age, sexual orientation or veteran status.
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
tas.nacomms@novartis.com 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.
The pay range for this position at commencement of employment is expected to be between $33.31 and $49.95/hour; 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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