drjobs Sr Analyst, Quality Control Cell-based methods

Sr Analyst, Quality Control Cell-based methods

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1 Vacancy
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Job Location drjobs

Durham - USA

Monthly Salary drjobs

$ 66800 - 124000

Vacancy

1 Vacancy

Job Description

Band

Level 2


Job Description Summary

The Senior Analyst Quality Control Cellbased methods will support activities within the Quality Control department with a focus on cellbased methods such as Adventitious Agents rcAAV potency etc. This role will utilize laboratory skills to test and measure product or materials while ensuring that analysis is performed according to established Standard Operating Procedures (SOPs) QC Methods & current Compendia. This role is based 100% onsite.

Location: Durhan NC #LIOnsite
Shift: 1st. Some night and weekend work may be required



Job Description

Key Responsibilities:

  • Executes routine and nonroutine analysis for cGMP release and characterization testing using techniques including but not limited to cellbased methods (potency AA) PCR (ddPCR qPCR) Immunoassays (ELISA) chromatography (HPLCUV HPLCELSD HPLCMS)AUC compendial assays (Bioburden pH) and electrophoresis (CE Western Blot).
  • 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.
  • 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

Essential Requirements:

  • Bachelors 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 including the critically thinking troubleshooting and problemsolving skills.
  • Normally receives general instructions on routine work detailed instructions on new projects or assignments.
  • Excellent interpersonal verbal and written communication skills with strong technical writing experience required and ability to work in a team environment.
  • Selfmotivated detailoriented and willing to accept temporary responsibilities outside of core duties.

Novartis Compensation and Benefit Summary: The pay range for this position at commencement of employment is expected to be between $32.12/hour and $59.62/hour; however while salary ranges are effective from 1/1/25 through 12/31/25 fluctuations in the job market may necessitate adjustments to pay ranges during this period. Further final pay determinations will depend on various factors including but not limited to geographical location experience level knowledge skills and abilities. The total compensation package for this position may also include other elements including a signon 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 atwill 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.



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 gender national origin age sexual orientation gender identity or expression marital or veteran status disability or any other legally protected status. We strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.



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 email to call 1 (877)and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Range

$66800.00 $124000.00


Skills Desired

Agility Audit Management Business Partnering Continued Learning Health Authorities Influencing Skills Knowledge Of Capa Quality Management Risk Management Root Cause Analysis (RCA) SelfAwareness Sop (Standard Operating Procedure) Technological Expertise

Required Experience:

Senior IC

Employment Type

Full-Time

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