Senior Analyst, Quality Control (Second Shift; 2-2-3 Rotational Schedule)

Full Time
Durham, NC 27713
Posted
Job description
Overview:
Imagine… 2 weeks after the birth of your child you realize they aren’t meeting critical developmental milestones and after months of doctor’s appointments you are told your baby has a rare neurological disease that would impact how they would live their lives. This is the reality of parents whose children have Spinal Muscular Atrophy (SMA) and it’s the reason why we at Novartis Gene Therapies are laser focused on bringing hope and possibility to those devastated by rare genetic diseases.
The Technician II, Warehouse, is responsible for end to end warehousing such as receiving, storing, sampling, issuing, cycle counting and processing of outgoing Fed-Ex parcel shipments.

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.
Responsibilities:
Second Shift; Rotational 2-2-3 Schedule. Approximately 2:00PM - 2:30AM and eligible for Shift Differential.
  • 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.
  • May facilitate training to other team members in the organization.
  • 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.
  • Other related job duties as assigned.
Qualifications:
  • Bachelor's degree in scientific disciplines such as Biochemistry, Biology, Microbiology or related field with 2 years’ experience in GMP environment.
  • Developing professional expertise, applies company policies and procedures to resolve a variety of issues.
  • 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.
  • Normally receives general instructions on routine work, detailed instructions on new projects or assignments.
  • Builds productive internal/external working relationships.
  • Excellent interpersonal, verbal and written communication skills with strong technical writing experience required and ability to work in a team environment.
  • Self-motivated, detail-oriented, and willing to accept temporary responsibilities outside of core duties.
  • Proficient in Microsoft Word, Excel, Power Point and other applications.
  • 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.


Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice. The level of this position will be based on the final candidate’s qualifications.


Why Novartis?

769 million lives were touched by Novartis medicines in 2020, 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 our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying! Imagine what you could do here at Novartis!


Commitment to Diversity & Inclusion:

Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve. Additionally, Novartis Gene Therapies is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, national origin, genetics, disability, age, sexual orientation or veteran status.


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 tas.nacomms@novartis.com 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.


The pay range for this position at commencement of employment is expected to be between $33.32/Hour and $49.95/Hour; 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

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