Qa Associate

2+ years

$55,000-$102,000

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 Associate

Job ID: REQ-10039680
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 QA Associate plays a critical role in ensuring the day-to-day operations of cGMP (current Good Manufacturing Practice) activities at the Morris Plains site. This position involves direct interaction with site staff responsible for daily operational functions in the production of quality pharmaceutical products. The QA Associate is essential in implementing quality strategies and driving continuous improvements in product and process quality across different departments.

Major Responsibilities

Batch Record & Documentation Review:
- Review and approve batch records, including apheresis and assay records, to ensure adherence to Novartis policies, Standard Operating Procedures (SOPs), and cGMP requirements.
Aseptic Operations:
- Perform routine shop floor tasks related to aseptic operations such as ViMOS, APV program observations, and conducting walkthroughs and QA area releases.
Event Management & Triaging:
- Under the guidance of the Quality Assurance Managers, assist in the triaging of events, including quality events, deviations, actions, and CAPA (Corrective and Preventive Actions).
- Partner with cross-functional departments during event triaging.
Process Improvement & Compliance:
- Actively engage in process improvement initiatives, focusing on Right First-Time (RFT) goals and adhering to regulatory and Novartis quality standards.
SOP Development & Self-Inspection Support:
- Write or review SOPs as needed.
- Assist in preparing documentation for self-inspections and external audits.
Quality Culture & Safety:
- Champion a culture of quality within the organization and maintain a safe working environment.
- Complete required job-related training.

Minimum Requirements

Educational Background:
- Associate's or Bachelor's degree in Biological Sciences or equivalent relevant career experience.
Experience:
- A minimum of 2 years of experience in a pharmaceutical or related environment.
Skills and Knowledge:
- Strong understanding of cGMPs and an ability to stay updated with industry trends and regulations.
- Excellent oral and written communication skills.
- Ability to demonstrate ownership of tasks and collaborate effectively with team members.
- Knowledge of SAP, 1QEM, MES, and LIMS is preferred.

Compensation and Benefits

Pay Range: $55,000 to $102,000/year (based on experience and location).
Additional Benefits:
- The total compensation package may include a sign-on bonus, restricted stock units, and discretionary awards.
- A comprehensive range of benefits including 401(k) eligibility, vacation, sick time, and parental leave.

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

Why Novartis?

Novartis is a global leader in innovative medicine, focused on improving and extending the lives of patients. The company fosters a collaborative environment where passionate and dedicated individuals work together to achieve breakthroughs in healthcare.

Commitment to Diversity & Inclusion

Novartis values diversity and is an Equal Opportunity Employer. We celebrate individual differences, backgrounds, and perspectives. We are committed to creating an inclusive work environment that reflects the communities we serve.

How to Apply

Apply directly through Novartis’ career portal. If this role doesn't align with your career goals, you can join the Novartis Talent Network to stay updated on future job opportunities.

This position provides an excellent opportunity to grow within a global pharmaceutical leader, making meaningful contributions to product quality and compliance.

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