QA Auditor, 3rd shift (2 openings) at Johnson & Johnson

Gurabo, Puerto Rico, Puerto Rico

Apply Now

Not SpecifiedCompensation

Junior (1 to 2 years), Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, Healthcare, MedTechIndustries

Requirements

Bachelor’s degree in Science with a major in Microbiology, Biology, Chemistry, or related science
Minimum of 2 years of work experience in the Pharmaceutical industry
Knowledge of Training System, Documentation System, Investigation and Change Control System, eLIMS
Ability to exercise judgment on the resolution of final release problems to meet company standards for quality, cost, and critical success factors
Proficiency in Spanish and English, with excellent technical writing ability in both languages
Availability to work 3rd shift, extended hours, holidays, and/or weekends
Up to 10% domestic and/or international travel may be required

Responsibilities

Review batch records thoroughly, perform continuous flow and quarantine assessments, and coordinate product disposition for WIPs, intermediates, finished goods, and raw materials (API and excipients) to ensure compliance with specifications and cGMP standards
Collaborate with cross-functional teams—Operations, Logistics, Warehouse, Technical Operations, Site Services, Quality Assurance, and QC Labs—to proactively identify, address, and resolve compliance issues
Make informed, data-driven recommendations and decisions to prevent process deviations, product non-conformances, and quality issues, bringing up critical concerns promptly
Document quality assessments, deviations, investigations, and corrective actions meticulously, ensuring full regulatory and internal compliance
Support continuous improvement by identifying process gaps, inefficiencies, and risks, and proposing effective corrective and preventive actions
Keep current with industry regulations, standards, and internal policies to uphold the highest quality standards
Ensure compliance with all material specifications, current Good Manufacturing Practices, and effective written procedures under the direction of the QA Supervisor

Skills

GMP

Quality Assurance

Batch Record Review

Product Disposition

Compliance Auditing

cGMP

QA Procedures

WIP Management

Raw Materials Inspection

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.

Land your dream remote job 3x faster with AI

Try Jobo Free