Process Quality Leader at Johnson & Johnson

San Lorenzo, Puerto Rico, Puerto Rico

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Healthcare, MedTech, Medical Devices, PharmaceuticalsIndustries

Requirements

Technical expertise in identifying causes of non-conformances and process failures
Knowledge of Ethicon’s QSR, GMP, and ISO requirements
Ability to provide technical leadership and mentorship to multifunctional, multilevel teams
Proficiency in data analysis, trend evaluation, and recommending process/equipment/system improvements
Skills in writing procedures, protocols, and documentation
Experience in leading investigations, CAPA (Corrective and Preventive Actions), PRE’s (Product Escalation Investigations), near misses, and QRB
Capability to provide training on process evaluation tools (e.g., analytical troubleshooting, FMEA, statistical concepts, QSR/ISO)
Compliance with environmental, safety, and occupational health policies (e.g., ISO14001, OSHAS 18001)
Ability to communicate business issues or opportunities to management

Responsibilities

Reviews and analyzes quality trends with the manufacturing team and sets priorities for process improvement
Provides mentorship to manufacturing supervisors for effective in-depth investigations
Leads multifunctional teams to identify non-conformance causes and implement corrective/preventive actions, evaluating their effectiveness
Leads investigations of negative trends and implements solutions with Process Engineer, Quality Engineering, manufacturing, and facilities
Analyzes data and recommends actions for process, equipment, and system improvements
Writes procedures, protocols, and documentation for process and system improvements
Provides training and education to operations on process evaluation and improvement tools
Leads CAPAs, recommends CAPAs based on trends, and handles PRE’s, near misses, and QRB
Leads in-process investigations to determine root causes and recommend corrections/preventive actions
Handles preliminary investigations of product complaints, including analysis, trends, and corrective/preventive actions
Provides technical supervision to Process Quality Technicians, College Recruits, Coops, or Supervisors on process improvement projects
Ensures compliance with all applicable laws, regulations, corporate procedures, and guidelines, including health, safety, and environmental policies
Communicates business-related issues or opportunities to the next management level

Skills

Quality Engineering

Process Improvement

Root Cause Analysis

GMP

QSR

ISO Standards

Supply Chain Engineering

CAPA

Trend Analysis

Investigations

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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