QC Chemist

The QC Chemist will support all technical aspects related to quality control testing readiness, including QC reagents and materials management, equipment preparation and daily cleaning and maintenance activities, sample management and QC testing, and documentation completion and review in full compliance with GMP regulation, procedures, and product specifications

Location: Indianapolis, IN #LI-Onsite

Shift- 1st Shift Thursday-Sunday 8 AM to 6 PM

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 preferred
• HPLC knowledge is required.
• Ability to interpret analytical data and convert into technical documentation.
• Basic knowledge and understanding of aseptic principles and techniques
• Quality Control Sampling
• Quality Control (QC Testing)
• General HSE knowledge

Novartis Compensation and Benefit Summary:

The salary for this position is expected to range between $85,400 and $158,600/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.

Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together?

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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, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status.

Accessibility & 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 to perform the essential functions of a position, please send an e-mail to [email protected] or call and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Division

Operations

Business Unit

Innovative Medicines

Location

USA

State

Indiana

Site

Indianapolis

Company / Legal Entity

U469 (FCRS = US469) AAA USA Inc.

Functional Area

Quality

Job Type

Full time

Employment Type

Regular

Shift Work

No