Περίληψη
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.
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EEO Statement:
The Novartis Group of Companies are Equal Opportunity Employers who are focused on building and advancing a culture of inclusion that values and celebrates individual differences, uniqueness, backgrounds and perspectives. 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. We are committed to fostering a diverse and inclusive workplace that reflects the world around us and connects us to the patients, customers and communities we serve.
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 +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
