Specialist, Quality Assurance – Quality Control

• Participates in establishment / revision of drug substance and drug product specifications for IND, IMPD, and BLA submissions.
• Provide QA oversite for the development, qualification, validation, and transfer of analytical methods.
• QA representative for the investigation and resolution of out-of-specification (OOS) and out-of-trend (OOT) testing results. Support QC CAPAs and Change Controls.
• Provides support to ensure successful accomplishment of business goals.
• Other related duties as assigned.
• Interprets characterization, product release, and stability data.
• Supports invalid assay and aborted assay investigations.
• Monitors routine method and equipment performance for trends and adherence to existing and new quality standards.

• Strong technical writing capabilities.
• Ability to work independently and effectively.
• Ability to prioritize and deliver on tight timelines.
• Outstanding problem-solving abilities.
• Bachelor's Degree in a scientific discipline with 5 years working experience in the Biotech/Pharmaceutical industry dependent and 5 years working directly with or supporting laboratory functions.
• Approximately 10% travel.
• Good critical thinking, deductive reasoning, and decision-making skills.
• Strong knowledge of USP, ICH, and Ph Eur regulations as they relate to Quality Control.
• Experience working with teams implementing lean processes into a GMP lab or manufacturing environment.

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.

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.

The pay range for this position at commencement of employment is expected to be between $42.30-63.46/hourly; 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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