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Associate Scientist, Qca (Sun-Wed Pm)

5+ years
$66,800-$124,000
10 Feb. 13, 2025
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Associate Scientist, QCA (Sun-Wed PM)

Job ID: REQ-10039492
Location: Morris Plains, New Jersey, USA
Division: Operations
Business Unit: Innovative Medicines
Functional Area: Quality
Job Type: Full-time
Employment Type: Regular


Shift Information

  • Shift: Sun-Wed PM
  • Work Hours: 2:30 PM - 1:00 AM
  • Number of Positions Open: 7

Role Overview

The Associate Scientist, QCA is responsible for performing testing and supporting activities within the Quality Control department. This includes Bio-Analytical testing, microbiological/environmental monitoring (EM), bioassay, raw material testing, and maintaining cell lines. The role will require working in a laboratory environment while adhering to GMP/GLP standards.


Key Responsibilities

  • Testing:

    • Perform various Bio-Analytical tests such as Flow, ELISA, cell count, cell viability, qPCR.
    • Conduct microbiological/EM testing, including gram stain, sterility, endotoxin, and mycoplasma.
    • Perform raw material testing using HPLC, GC, FTIR, osmolarity, and other techniques.
  • Lab Maintenance:

    • Maintain controls and reference standards to support testing.
    • Manage the upkeep of cell lines and cell banks.
  • Data Review:

    • Review and approve data generated by other team members.
  • Methodology:

    • Conduct method qualification and optimization as per protocols.
  • Investigations:

    • Contribute to OOS/OOE and deviation investigations.
  • System Knowledge:

    • Utilize LabWare LIMS or other QC data systems for documentation and tracking.
  • Quality Compliance:

    • Follow GMP/GLP quality systems and adhere to company policies.

Role Requirements

  • Educational Background:

    • BA or MS in chemistry, biochemistry, microbiology, or a related science.
  • Experience:

    • 0-5 years of experience in the pharmaceutical, biologics, microbiology, sterile manufacturing, or medical device industry.
  • Technical Skills:

    • Knowledge of cGMP, GLP, FDA guidelines, and other industry standards (e.g., ANSI, ISO).
    • Experience with microbiological/EM testing, bioassay, and raw material testing is desirable.
    • Familiarity with LIMS systems.
  • Communication Skills:

    • Strong written and verbal communication abilities.
    • Ability to communicate effectively with various departments within Novartis.
  • Other Skills:

    • Detail-oriented with strong problem-solving and decision-making abilities.

Why Novartis?

Novartis aims to reimagine medicine to improve and extend lives. As a company, they focus on fostering a community of passionate individuals working together to achieve breakthroughs that change patients' lives.

Compensation and Benefits:
The pay range for this role is between $66,800 and $124,000/year, with additional benefits like 401(k) eligibility, paid time off, and potential bonuses. Full details on benefits can be found here.


Commitment to Diversity & Inclusion

Novartis values diversity and inclusion, ensuring equal opportunities for all employees regardless of race, gender, age, or background. The company is dedicated to fostering an inclusive environment where differences are celebrated.


Join Novartis Network

If this role isn't a fit but you wish to stay updated on future opportunities, join the Novartis talent community.


This position provides an exciting opportunity to be part of Novartis's mission to innovate in the healthcare field and deliver life-changing therapies to patients.