QC Specialist Tech Resources & Compliance

REQ-10020076
Sep 03, 2024
USA

Summary

-This position will support activities within the Quality Control department, with a focus on technical items for QC, compliance and continuous improvement. This role will utilize strong cGMP understanding and scientific knowledge to perform Change Controls, investigations, technical review, etc. This role requires strong project management and communication skills to coordinate and implement cross-functional projects, ensuring timely and compliant execution. This role is based 100% on-site.

Novartis is unable to pay relocation for this role so please ensure you are able to work from this location.

About the Role

Key Responsibilities:

  • Authors QC investigations and meets all targets for timely closure and CAPA completion.
  • Coordinate with Quality to ensure compliance and continuous improvement in the QC labs.
  • Coordinates change control for method related changes.
  • Perform technical review of QC assays for cGMP release and characterization testing, including but not limited to cell-based methods (potency, AA), PCR (ddPCR, qPCR), Immunoassays (ELISA), chromatography (HPLC-UV, HPLC-ELSD, HPLC-MS), AUC, compendial assays (Bioburden, pH) and electrophoresis (CE, Western Blot).
  • Authors technical documents such as Protocols / Reports.
  • Works with the greater QC team to ensure updates of SOP, WP, Form, etc.
  • Supports regulatory inspections.
  • Capable of delivering to assigned work schedule with attention to detail and accuracy.
  • Perform laboratory testing as required.
  • Other duties QC is responsible for, as assigned.

Requirements: 

  • Bachelor's degree in scientific disciplines such as Biochemistry, Biology, Microbiology or related field with 5 years’ experience in GMP environment.
  • Excellent interpersonal, verbal and written communication skills with strong technical writing experience required. Previous investigation experience a plus.
  • Proven ability to work effectively in a team environment. Collaborates cross functionally with other departments to achieve site goals.
  • Works on problems of moderate scope where analysis of situations or data requires a review of a variety of factors. 
  • Exercises judgment within defined procedures and practices to determine appropriate action including critically thinking, troubleshooting and problem-solving skills.
  • Normally receives general instructions on routine work, detailed instructions on new projects or assignments.
  • Self-motivated, detail-oriented, and willing to accept temporary responsibilities outside of core duties.

#LI-Onsite

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

Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network

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

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.

TEst Hello

Operations
Innovative Medicines
USA
North Carolina
Durham
Quality
Full time
Regular
No

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.

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

Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network

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

Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network

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.

A female Novartis scientist wearing a white lab coat and glasses, smiles in front of laboratory equipment.
REQ-10020076

QC Specialist Tech Resources & Compliance

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Source URL: https://dev1.novartis.de/careers/career-search/job/details/req-10020076-qc-specialist-tech-resources-compliance

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  1. https://www.novartis.com/about/strategy/people-and-culture
  2. https://talentnetwork.novartis.com/network
  3. https://www.novartis.com/careers/benefits-rewards
  4. https://novartis4.wd3.myworkdayjobs-impl.com/en-US/Novartis_Careers/job/Durham/QC-Specialist-Tech-Resources---Compliance_REQ-10020076-2
  5. https://www.novartis.com/about/strategy/people-and-culture
  6. https://talentnetwork.novartis.com/network
  7. https://www.novartis.com/careers/benefits-rewards
  8. https://talentnetwork.novartis.com/network
  9. https://novartis4.wd3.myworkdayjobs-impl.com/en-US/Novartis_Careers/job/Durham/QC-Specialist-Tech-Resources---Compliance_REQ-10020076-2