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

Gurabo, Puerto Rico, Puerto Rico

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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 a regulated 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
Willingness to travel up to 10% domestically and/or internationally

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

Skills

Key technologies and capabilities for this role

GMPQuality AssuranceBatch Record ReviewProduct DispositionCompliance AuditingcGMPQA ProceduresWIP ManagementRaw Materials Inspection

Questions & Answers

Common questions about this position

Is this a remote position or does it require on-site work?

This is an on-site position located in Gurabo, Puerto Rico, with no mention of remote work options.

What are the key responsibilities of the QA Auditor role?

Key responsibilities include reviewing batch records, performing continuous flow/quarantine processes and product disposition, collaborating with cross-functional teams to resolve compliance issues, making recommendations to prevent deviations, documenting assessments, and supporting continuous improvement.

What shift does this QA Auditor position work?

The position is for the 3rd shift.

What is the salary or compensation for this role?

This information is not specified in the job description.

What kind of experience or skills make a strong candidate for this QA Auditor position?

Strong candidates should have expertise in ensuring compliance with cGMP, reviewing batch records, performing product disposition, collaborating across teams like Operations and QC Labs, and supporting continuous improvement initiatives.

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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