QC Senior Specialist Job at Novartis, Durham, NC

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  • Novartis
  • Durham, NC

Job Description

~~~Please note: This is a temporary contractor opportunity at Novartis ~~~
Novartis touches the lives of a tenth of the world’s population. Every role here, regardless of contract type, makes an impact on human life!

Novartis US partners with external managed service provider Magnit Global to offer engaging temporary contractor opportunities like this, to those who are looking for flexibility in their career while looking to gain new skills and experiences providing services to an inclusive global medicines company. Click here to learn more about Magnit

Ready to work with/through Magnit at Novartis? Please read on...
QC Senior Specialist

The Specialist, Quality Control, assists and supports the organization with compliance and ongoing preparation, testing and monitoring of conformance to established quality processes and standards for manufacturing and production.

Responsibilities:
• Act a coordinator for Quality activities including site to site method transfer and internal project coordination.
• Assists in the evaluation of internal controls, communications, risk assessments and maintenance of documentation as related to compliance with internal and external safety, quality, and regulatory standards.
• Reviews data obtained for compliance to specifications and reports abnormalities. Performs trend analysis of methods /environmental data / assay controls & standards and draws conclusions.
• Capable of delivering to assigned work schedule with attention to detail and accuracy.
• Support department risk assessments and participates in audit walk-throughs.
• Participates in the preparation of investigations, summaries and reports. Reviews data obtained for compliance to specifications and reports Investigates and resolves non-conforming test results by completing thorough Deviation, OOS/OOT/OOE and Investigation.
• Authors new/revise Standard Operating Procedures, Protocols / Summary Reports /Analytical Master Plans for QC.
• Oversees special projects on analytical and instrument problem solving. May develop testing and analysis methods and procedures in accordance with established guidelines.
• Supports training of departmental personnel in appropriate technique and related topics.
• Other related job duties as assigned.

Requirements:
• Bachelor's degree in scientific disciplines such as Biochemistry, Biology, Microbiology or related field with 8 years’ experience in GMP environment or 7 years’ at GTx.
• Familiarity with cGMP release and characterization testing using techniques including but not limited to cell-based methods (potency, AA), PCR (ddPCR, qPCR), Immunoassays (ELISA), chromatography (HPLC-UV), AUC, compendial assays (Bioburden, pH), electrophoresis (CE, Western Blot), cell culturing, and Microbiology/Release sampling (EM, Compressed Gas).
• 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.

Location: Durham, NC (Onsite)
Pay Rate: $30 - $35/hr based on experience and qualifications (W2 Only)
Contract: 12+month 
Health, dental, vision, 401k

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?

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.

Accommodation: 
If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to Magnit at directsourceproteam@prounlimited.com.

 

Job Tags

Contract work, Temporary work, For contractors,

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