~~~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 www.magnitglobal.com
Ready to work with/through Magnit at Novartis? Please read on...
~~~~~2024 Future Planning need in Durham, NC~~~~~
The Specialist - Quality Control, assists and supports the organization with initial compliance and ongoing preparation, testing and monitoring
of conformance to established quality processes and standards for manufacturing and production.
Responsibilities:
• Executes routine and non-routine analysis, may include, but not limited, to cGMP release and characterization testing using
analytical techniques such as potency, PCR (ddPCR, qPCR), Immunoassays (ELISA), chromatography (HPLC-UV, HPLCELSD, HPLC-MS), spectrophotometry, AUC, and electrophoresis (CE, PAGE, western blotting).
• 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.
• Conducts routine and non-routine analysis, including but not limited to biochemical and chemical analysis, of raw materials,
in-process items and finished product according to established operating procedures.
• Compiles data for documentation of test procedures that may include stability program testing and formulation studies.
• Supports Quality Control department at QMR by preparing slide deck and presenting laboratory metrics.
• 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.
• Champion’s continuous improvement projects to maximize laboratory efficiencies and to strengthen compliance.
• Other related job duties as assigned.
Requirements:
•Bachelor's degree in scientific disciplines such as Biochemistry, Biology, Microbiology or related field with 5 years’ experience in GMP environment.
• Full understanding of area of specialization; resolves a wide range of issues in creative ways.
• Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors.
• Demonstrates good judgment in selecting methods and techniques for obtaining solutions.
• Ability to receive little instruction on day-to-day work, general instructions on new assignments.
• Networks with senior internal and external personnel in own area of expertise.
• Excellent interpersonal, verbal and written communication skills with strong technical writing experience.
• Possess a strong understanding of QC testing technique.
• Proficient in Microsoft Word, Excel, Power Point and other applications.
• Extensive knowledge of GLP and GDocP principles.
• An understanding of FDA/EMEA regulations.
Location: Durham, NC (Onsite – shifts TBD)
Pay Rate: $40-$51/hour Based on:market location, job-related knowledge, skills, experience, etc.
Contract: 6+ months
Health, dental, vision, 401k
Why Novartis?
766 million lives were touched by Novartis medicines in 2021, 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.
We believe we can reinvent what's possible when we collaborate with courage to ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying!
Imagine the impact you could make here at Novartis!
Commitment to Diversity & Inclusion:
Novartis is committed to building an outstanding, inclusive work environment with diverse teams representative of the patients and communities we serve.
To do our best work we need different viewpoints, which is why here at Magnit, we celebrate diversity and embrace inclusion. As an equal opportunity employer, Magnit is dedicated to building a team that represents a variety of backgrounds, perspectives, and skills. We strive to ensure that we maintain a positive and enriching work environment for all.
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 or 1.862.778.5441.
Commitment to Diversity and Inclusion / EEO
