Key Responsibilities:

• Finished Product testing, Environmental Monitoring and Sterility QC testing, and reporting of the QC results.
• Escalation in case of non-conformances and deviations and manage these quality incidents as per procedures.
• Support deviation investigations, OOS/OOT/OOE investigations, CAPA follow up and implementation, and Change Control management, including procedure and form revisions.
• Participation in assigned qualification/validation activities, as necessary.
• Responsible for successful on time completion of required training curricula comprising of the necessary Standard Operating Procedures (SOPs) and Aseptic Techniques, Gowning Qualifications, Testing and specifications, and other relevant training including HSE for the specific role.
• Prepares applicable documents, forms, and records such as analytical batch records and follows Good Documentation Practices.
• Support internal and external Audits and Inspections, as required.

Essential Requirements:

• Education: Bachelors' degree required in relevant Scientific discipline (e.g Chemistry, Microbiology).
• Minimum of 3-year experience in cGMP or aseptic environment required.
• Knowledge of cGMP regulations and FDA guidance applicable to Quality Control for product and Environmental Monitoring testing, as well as Aseptic techniques.
• Practical experience with Microbiology method verification and routine testing practices, EM Monitoring and basic knowledge of method/equipment validation principle and methodologies.
• Ability to interpret analytical data and convert into technical documentation.
• Basic knowledge and understanding of aseptic principles and techniques

Novartis Compensation and Benefit Summary:

The salary for this position is expected to range between $89,600 and $166,400/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 benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves.