Qa Specialist

3+ years

$85,400-$158,600

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: QA Specialist

Job ID: REQ-10039683
Location: Morris Plains, New Jersey, USA
Division: Operations
Business Unit: Innovative Medicines
Functional Area: Quality
Job Type: Full-time
Employment Type: Regular

About the Role

The Quality Assurance Specialist will support the day-to-day cGMP activities at the Morris Plains site. This role focuses on ensuring product quality by working directly with site staff to facilitate operational functions such as making, testing, and releasing products. The position is onsite and requires a hands-on approach to improving process quality within production units, QC labs, and other support areas.

Key Responsibilities

Shopfloor Activities:
- Conduct routine activities on the shop floor related to aseptic operations, including ViMOS, APV observations, walkthroughs, and QA area releases.
- Provide QC Floor support and ensure compliance with cGMP.
Event Management:
- Triaging events on the shop floor and initiating deviation records in the deviation management system for both PU and QC laboratories.
Documentation Review:
- Review and audit production batch records and QC documentation to ensure compliance with Novartis policies, SOPs, and cGMP.
Compliance & Release Activities:
- Collaborate closely with PU and QC teams to resolve batch record/QC data issues, ensuring timely and robust product disposition in accordance with GMP and regulatory requirements.
Process Improvement:
- Actively contribute to initiatives aimed at achieving Right First Time (RFT) documentation and deviation reduction.
SOP Management:
- Write, review, and approve Standard Operating Procedures (SOPs), Work Procedures (WPs), and Forms (FRMs).

Desirable Requirements

Educational Background:
- BS/BA in Biological Sciences or equivalent relevant experience.
Experience:
- 3+ years of experience in a pharmaceutical environment.
- Strong knowledge of cGMPs, industry regulations, and current best practices.
Technical Skills:
- Familiarity with Deviation Management, batch disposition, and aseptic techniques.
- Knowledge of SAP, 1QEM, MES, and LIMS is preferred.
Communication Skills:
- Excellent written and verbal communication skills.
Leadership & Teamwork:
- Demonstrated leadership abilities and interpersonal skills to work effectively with teams.
- Ability to work independently or in a team.

Compensation and Benefits

Pay Range: $85,400 to $158,600/year, depending on experience and location.
Additional Benefits:
- Sign-on bonuses, restricted stock units, and discretionary awards.
- Comprehensive medical, financial, and other benefits, including 401(k), paid time off, and parental leave.

For more details on benefits, visit the Novartis Benefits and Rewards Handbook.

Why Novartis?

Novartis is focused on helping people with diseases and their families through innovative science and a community of passionate, collaborative people. The company values diversity and fosters an inclusive workplace where everyone can thrive and contribute to making a difference in patients' lives.

Commitment to Diversity & Inclusion

Novartis is an Equal Opportunity Employer, committed to building and advancing a diverse and inclusive culture.

How to Apply

If you are interested, apply directly through the Novartis career portal. If this role isn't a perfect fit, consider joining the Novartis Talent Network to stay informed about future opportunities.

This position provides an exciting opportunity to support critical quality assurance activities in a pharmaceutical setting and contribute to improving healthcare.

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