The Senior Analyst, 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.
Your responsibilities include, but are not limited to:
• 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, HPLC-ELSD, HPLC-MS), spectrophotometry, AUC, and electrophoresis (CE, PAGE, western blotting).
• Ensures assigned to specific disciplines, but will support all necessary laboratory and assay functions, including housekeeping, safety, logbook/equipment use and maintenance, and updates to existing and authors new operating procedures.
• Capable of delivering to assigned work schedule with attention to detail and accuracy.
• Notifies management, initiates (such as Laboratory Investigations) and authors minor events/discrepancies in the quality systems, with little to no guidance from advisor or management.
• Leads special projects on analytical and instrument problem solving by execution of assay.
• May develop testing and analysis methods and procedures in accordance with established guidelines.
• Understands the basic process improvement methodologies, learning and applying concepts of lean lab and six sigma that are applicable to the QC lab environment.
• Ensures calibrates and maintains lab and analytical equipment are performed within established period.
• Conducts review of logbooks and may perform reviews as assigned by management
• May assist in drafting technical documents such as Protocols / Report to support method verification/validations.
(Second Shift 3PM to 1:30AM: M, T, Th, F)
Minimum requirements
Education:
• Bachelor’s degree in scientific disciplines such as Biochemistry, Biology, Microbiology or related field with 2 years’ experience in GMP environment.
Experience:
• 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.
• Excellent interpersonal, verbal and written communication skills with strong technical writing experience required and ability to work in a team environment.
• Proficient in Microsoft Word, Excel, Power Point and other applications.
• Detail-orientated, ability to think critically and demonstrate troubleshooting and problem-solving skills.
• Ability to gown for entry into Aseptic core and supporting areas and lift approximately 25 pounds.
Why Novartis: Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here:
https://www.novartis.com/about/strategy/people-and-culture.
The pay range for this position at commencement of employment is expected to be between $33.31 and $49.95 hourly; however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors. You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. https://www.novartis.com/careers/benefits-rewards
You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook: https://www.novartis.com/careers/benefits-rewards
Accessibility and 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 in order to perform the essential functions of a position, please send an e-mail to [email protected] 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.
Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: Novartis Talent Pool.
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