Associate Scientist, Qca (Wed-Sat Am)

5+ years

Not Disclosed

United States

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 (Wed-Sat AM)

Job ID: REQ-10039472
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: Wed-Sat AM
Work Hours: 7:30 AM - 6:00 PM
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 performing Bio-Analytical testing, microbiological/environmental monitoring (EM), bioassay, raw material testing, and maintaining cell lines. The role will be carried out in accordance with GMP/GLP standards.

Key Responsibilities

Testing:
- Perform Bio-Analytical testing, including Flow, ELISA, cell count, cell viability, qPCR.
- Conduct microbiological/EM testing, such as gram stain, sterility, endotoxin, and mycoplasma.
- Perform raw material testing using techniques such as HPLC, GC, FTIR, and others.
Lab Maintenance:
- Maintain controls and reference standards.
- Oversee the upkeep of cell lines and cell banks.
Data Review:
- Review and approve data produced by other team members.
Methodology:
- Carry out method qualification and optimization according to protocols.
Investigations:
- Assist in OOS/OOE and deviation investigations.
System Knowledge:
- Utilize LabWare LIMS or other QC data systems for tracking and documentation.
Compliance:
- Maintain GMP/GLP quality systems and comply with quality 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 in microbiological/EM testing, bioassay, and raw material testing.
- Familiarity with LIMS systems.
Communication Skills:
- Strong written and verbal communication skills.
- Ability to collaborate with different teams at Novartis.
Other Skills:
- Highly detail-oriented with strong problem-solving abilities and decision-making skills.

Why Novartis?

Novartis is dedicated to reimagining medicine to improve and extend people's lives. As part of their mission, Novartis fosters a culture of collaboration and innovation. The company emphasizes the role of its people in achieving breakthroughs and delivering transformative therapies.

Compensation and Benefits:
The pay range for this position is between $66,800 and $124,000/year, with additional compensation components such as sign-on bonuses, restricted stock units, and comprehensive benefits. Full details of benefits can be found here.

Commitment to Diversity & Inclusion

Novartis is committed to creating an inclusive work environment that values diversity. They celebrate the uniqueness of their associates and seek to ensure that everyone feels respected and supported.

Join the Novartis Network

If this role doesn’t align with your experience but you want to stay connected for future opportunities, you can join the Novartis talent community.

This position offers an exciting opportunity to be part of Novartis's global mission to innovate in the healthcare sector and change patients' lives.

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Associate Scientist, Qca (Wed-Sat Am)

Job Description

Job Title: Associate Scientist, QCA (Wed-Sat AM)

Shift Information

Role Overview

Key Responsibilities

Role Requirements

Why Novartis?

Commitment to Diversity & Inclusion

Join the Novartis Network

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