QA Associate

Novartis Group Companies; Morris Plains (NJ); On-site; USD 55,000 - 102,000; Full time

Job summary

An established industry player is seeking a Quality Operations Associate to ensure compliance with cGMP standards at their Morris Plains site. This hands-on role involves reviewing batch records, conducting shop floor tasks, and engaging in process improvements. The ideal candidate will possess a strong background in biological sciences and experience in the pharmaceutical sector. Join a team that champions a quality culture and promotes continuous improvement in product and process quality. This is a fantastic opportunity to contribute to a leading organization committed to excellence in the healthcare industry.

Qualifications

• 2+ years of experience in a pharmaceuticals environment.
• Knowledge of cGMPs and industry regulations.

Responsibilities

• Review and approve batch records and ensure cGMP compliance.
• Conduct routine shop floor tasks related to aseptic operations.

Skills

cGMP Knowledge

Communication Skills

Interpersonal Skills

Process Improvement

Education

Associate or BA degree in Biological Sciences

Tools

SAP

1QEM

MES

LIMS

Job description

Job Description Summary

This position will be located at the Morris Plains, NJ site and will not have the ability to be located remotely. It requires 0% travel, as defined by the business (domestic and/or international).

The Quality Operations Associate is responsible for the first-level, hands-on, day-to-day cGMP facilitator role for all site-related GMP activities. The QA Associate will interact directly with site staff performing daily operational functions to produce quality products. This role ensures the implementation of the quality strategy and promotes continuous improvement in product and process quality.

Hours and Shifts:

• Sun-Wed 6:00am-4:00pm
• Sun-Wed 12:00 pm-10:00pm
• Wed-Sat 6:00am-4:00pm
• Wed-Sat 12:00pm-10:00pm

Major accountabilities:

1. Review and approve batch records, Apheresis, Aborted and Invalid Assays, etc., ensuring adherence to Novartis policies, SOPs, and cGMP requirements.
2. Conduct routine shop floor tasks related to aseptic operations, including ViMOS, APV observations, walkthrough programs, QA area release, etc.
3. Under the guidance of the Quality Assurance Managers, perform triaging and initiation of events such as Quality Events, Deviations, Actions, CAPAs, etc., working with cross-functional departments.
4. Engage in process improvement and Right First-Time initiatives at the Morris Plains site, ensuring compliance with regulations and quality standards.
5. Write and review Standard Operating Procedures (SOPs) as needed.
6. Assist in providing documentation for self-inspections and external audits.
7. Champion a Quality Culture and ensure a safe working environment.
8. Complete job-related training as required.
9. Demonstrate and role model Novartis values and behaviors.

Minimum Requirements:

• Associate or BA degree in Biological Sciences or equivalent relevant experience.
• Minimum of 2 years of experience in a pharmaceuticals environment.
• Knowledge of and understanding of cGMPs, current industry issues, and regulations.
• Excellent oral and written communication skills.
• Ownership of daily tasks and strong interpersonal skills.
• Ability to work independently, under direction, and as part of a team.
• SAP, 1QEM, MES, LIMS knowledge preferred.

Additional Information:

The salary range at the start of employment is expected to be between $55,000 and $102,000/year. Salary may fluctuate during 2025 based on market conditions and other factors. The total compensation may include bonuses, stock units, and other benefits, which will be detailed upon offer. This position is at-will, and the company may modify compensation at any time.

Company will not sponsor visas. Relocation support is not provided; only apply if the location is accessible to you.

EEO and Accessibility:

We are committed to an inclusive workforce and do not discriminate based on legally protected statuses. Reasonable accommodations are available for applicants with disabilities; contact [e-mail] or call [phone], including the job requisition number.