~~~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…
Associate Expert - Microbiology
Under general direction, perform microbiology/EM testing and other activities in functions supporting the Quality Control department.
Main activities
• Perform micro/EM testing in support of clinical release strategies.
• Perform all testing and activities compliantly following appropriate SOPs and procedures.
• Maintain controls and reference standards to support testing.
• Executes and follows SOPs, WPs, and quality policies.
• Peer review and archive analytical data in lab documentation systems.
• Support monthly/quarterly laboratory cleaning.
• Appropriate use of laboratory logbooks and monthly laboratory cleaning.
• Manage reagent/consumable inventory and equipment cleaning for assigned areas of responsibilities.
• Ensures cleanliness of laboratory working areas.
• Support and author OOS/OOE/OOT and deviation investigations.
• Participate in CAPA implementation in a timely manner.
• Follows GxP quality policies and procedures.
• Ensures all assigned training is completed within required time frame.
• Support 5S and Lean projects.
• Identify process improvements.
• Knowledge of LabWare, LIMS and/or other QC data systems.
• Knowledge of appropriate GMP/GLP quality systems (e.g., ESOPs, Trackwise, 1QEM, BMRAM, etc.).
• Support execution method qualification/optimization of methods.
• Interface with regulatory agencies during audits as required.
• In addition to these primary duties, provide coverage for all appropriate areas.
• Contributes to assigned projects by following predefined tasks and executing as instructed.
• Perform other job duties as assigned.
Additional specific roles/tasks
• Collects and generates data for trend reporting.
• Verify the accuracy of data generated.
• Contributes to the gowning qualification program by taking samples and analyzes and generates data.
Education (minimum/desirable):
BA/BS or MS or advanced degree in microbiology, biology, biochemistry, or other related science or equivalent work experience.
Experience/Professional requirement:
1 - 3 years of relevant experience in the pharmaceutical, biologics, microbiology, sterile manufacture, or medical device industry.
Knowledge of cGMP and an understanding of the concepts of GDP, good clinical practices and FDA guidelines, applicable state and foreign regulations, and standards routinely used in the industry (i.e., ANSI, ISO, etc.).
Thorough knowledge of microbiological and environmental monitoring, test methods.
Microbiology/Environmental Monitoring knowledge to facilitate investigations.
Knowledge of LIMS systems.
Ability to communicate clearly with a variety of individuals in various aspects of Novartis operations.
Detail-oriented with expertise in problem solving and solid decision-making abilities.
Strong interpersonal skills which include a professional demeanor when interacting with Novartis personnel.
Strong written and verbal communication skills are essential.
Location: East Hanover, NJ (Onsite)
Shift: 12 PM to 8 PM (M-f) & work one or both weekend days at least once per month. Shifts will be fixed based on business needs.
Pay Rate: $26 - $35/hour (W2 Only based on experience and qualifications
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 [email protected].