QA Associate at Johnson & Johnson

Ghent, Flanders, Belgium

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Not SpecifiedCompensation

Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Healthcare, Pharmaceuticals, BiotechnologyIndustries

Requirements

A degree in Pharmacy, Biotechnology, Bio-engineering or a related field
Minimum 3 years of cross-functional experience in the pharmaceutical industry
In-depth understanding of pharmaceutical product development, qualification, packaging, validation, testing, release, and distribution processes. Experience with cell and gene therapy, specifically CAR-T, is preferred
Up-to-date knowledge of pharmaceutical legislation, including current Good Manufacturing Practices (cGMP) and Advanced Therapy Medicinal Products (ATMP) regulations
Strong analytical thinking and decision-making abilities, with a keen attention to detail
Excellent verbal and communication skills

Responsibilities

Investigation Support: Provide technical, quality, and compliance expertise to support in-depth investigations related to deviations to ensure timely resolution
Deviation Management: Ensure that deviations are promptly and thoroughly investigated, with particular attention to those that may affect patient safety or product supply. Escalate issues that could have significant impacts on quality
CAPA Management: Ensure that appropriate corrective and preventive actions (CAPAs) are identified and implemented in response to investigations, especially those with potential impacts on product quality and patient safety
Quality Oversight Participation: Contribute to the quality oversight programs by providing documented QA approval for GMP documentation and actively participating in quality review meetings to support operational activities
Inspection and Audit Support: Assist in the preparation, execution, and follow-up of internal and external inspections and audits to ensure compliance with Good Manufacturing Practices (GMP) and other regulatory requirements
Collaboration and Stakeholder Engagement: Foster and maintain effective working relationships with internal teams, business partners, and external collaborators (e.g., Legend Biotech), ensuring alignment with quality objectives and deliverables

Skills

Key technologies and capabilities for this role

Quality EngineeringDeviation InvestigationsRegulatory ComplianceManufacturing ProcessesCAR-T TherapiesGMPRoot Cause AnalysisCross-functional CollaborationTechnical OperationsQuality Control

Questions & Answers

Common questions about this position

What is the location for this QA Associate position?

The position is located in Gent, East Flanders, Belgium.

What are the main responsibilities of this role?

Responsibilities include providing investigation support for deviations, managing deviations and CAPAs, participating in quality oversight, supporting inspections and audits, and collaborating with cross-functional teams.

What teams will I work with in this position?

You will report to the J&J QA CAR-T organization and work closely with peers from Material Science and Technology, Operations, Quality Control, Technical Operations, Manufacturing, Vein-to-Vein department, and Regulatory affairs.

Is the employment full-time?

Yes, this is a full-time position.

What salary or compensation is offered for this role?

This information is not specified in the job description.

Johnson & Johnson

Healthcare products in pharmaceuticals and devices.

About Johnson & Johnson

Johnson & Johnson operates in the healthcare sector with three main areas: pharmaceuticals, medical devices, and consumer health products. In the pharmaceuticals segment, the company develops prescription drugs for various medical conditions such as cancer and infectious diseases. The medical devices segment provides products used in surgeries and other medical procedures, while the consumer health segment offers over-the-counter products, including baby care and personal health items. Johnson & Johnson generates revenue through direct sales and partnerships, and it invests significantly in research and development to create new products that meet the needs of consumers and healthcare providers. The company stands out from competitors by emphasizing diversity, equity, and inclusion in its workplace, fostering an environment where employees can share their perspectives. Its goal is to improve patient outcomes and enhance the overall health and well-being of individuals globally.

New Brunswick, New JerseyHeadquarters

1886Year Founded

IPOCompany Stage

HealthcareIndustries

10,001+Employees

Risks

J&J faces a class action lawsuit in Australia over ineffective cold and flu medications.

Former J&J executives joining other firms could lead to increased competition.

Ongoing legal battles, like the lawsuit against Cigna, pose financial liabilities for J&J.

Differentiation

J&J operates in three segments: pharmaceuticals, medical devices, and consumer health.

The company invests heavily in R&D for innovative medical solutions and products.

J&J is committed to diversity, equity, and inclusion in its workplace culture.

Upsides

J&J's collaboration with Helsinki University Hospital focuses on value-based healthcare models.

The rise of personalized medicine offers J&J opportunities in targeted therapies.

Increased focus on digital health solutions presents expansion opportunities for J&J.

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