Associate Expert Science & Technology, Quality Control (Shift Position: Mon-Thurs)

Your Key Responsibilities:

Your responsibilities include, but are not limited to:

• **Shift position**  Shift: Monday-Thursday 8am-6pm. Shift will be fixed according to business need.
• Perform bioanalytical testing in support of clinical release strategies.
• Perform all testing and activities compliantly following appropriate SOPs and procedures.
• Maintain controls and reference standards to support testing.
• Executes and follows SOPs, WPs, and quality policies.
• Peer review and archive analytical data in lab documentation systems.
• Support monthly/quarterly laboratory cleaning.
• Manage reagent/consumable inventory and support equipment cleaning for assigned areas of responsibilities.
• Ensures cleanliness of laboratory working areas.
• Support and author OOS/OOE/OOT and deviation investigations.
• Participate in CAPA implementation in a timely manner.
• Follows GxP quality policies and procedures.
• Ensures all assigned training is completed within required time frame.
• Support 5S and Lean projects.
• Identify process improvements.
• Knowledge of LabWare, LIMS and/or other QC data systems.
• Knowledge of appropriate GMP/GLP quality systems (ESOPs, Trackwise, BMRAM, etc.).
• Support execution method qualification/optimization of methods.
• Interface with regulatory agencies during audits as required.
• In addition to these primary duties, provide coverage for all appropriate areas.
• Contributes to assigned projects by following pre-defined tasks and executing as instructed.
• Performs other job duties as assigned.

Role Requirements:

• Bachelors degree in cell biology, immunology, molecular biology, virology, biochemistry, microbiology, or other related science.
• At least 1 year of experience in the pharmaceutical, biologics, microbiology, sterile manufacture, or medical device industry, ideally in a QC laboratory setting.
• Understanding of bioassay test methods (Elisa, flow cytometry, qPCR, cell culture) is required.
• Strong written and verbal communication skills are essential.
• Experienced in the use of computer -based systems and applications.

Desired Requirements:

• Understanding of the concepts of cGxP is preferred
• Knowledge of CAPA is preferred
• experience with Root Cause Analysis (Rca) is preferred

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? https://www.novartis.com/about/strategy/people-and-culture

Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards

Commitment to Diversity & Inclusion: The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. 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 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.

Novartis Compensation and Benefit Summary: The pay range for this position at commencement of employment is expected to be between $59,000-$89,900; however, while salary ranges are effective from 1/1/24 through 12/31/24, fluctuations in the job market may necessitate adjustments to pay ranges during this period.  Further, final pay determinations will depend on various factors, including, but not limited to geographical location, experience level, knowledge, skills, and abilities. 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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