Top 39 Quality control Jobs in San Juan Pr

Quality Assurance Specialist - GMP Manufacturing
Pinnaql, Inc —San Juan, PR
- $32.48 - $40.83 an hour
- Full-time
- Spanish
- Microsoft Excel
- English
Quick Apply
14d
Quality Auditor
West Pharmaceutical Services —Cidra, PR
- Background check
- Computer literacy
- English
- Tuition reimbursement
- Paid time off
4d
Quality - Quality Assurance Inspector I
Viant Medical —Vega Baja, PR
- Full-time
- English
- Windows
- Associate's degree
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JR Validation Specialist (Entry Level)
Validation & Engineering Group —San Juan, PR
- Entry level
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Quality Control Manager Bilingual for Federal Contract
Allied Universal —Guaynabo, PR
- $72,000.24 a year
- Full-time
- Bilingual
- Military
- High school diploma or GED
- AD&D insurance
- Paid holidays
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Quality Technician
ABB Installation Products Caribe LLC —Vega Baja, PR
- Full-time
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Quality Assurance Specialist – Utilities & Environmental Monitoring
Mentor Technical Group —Carolina, PR
- Full-time
- Mid-level
- 3 years
- Continuous improvement
Quality Representative
Ballester Hermanos, Inc. —Dorado, PR
- Full-time
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12d
Oficial de Calidad y Cumplimiento
Efraín Núñez Inc. —Guaynabo, PR
- $15 an hour
- Full-time
- Bachelor's degree
- In-person
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9d
Técnico de Validación en Producción
UPTURN —Gurabo, PR
- Full-time
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Petroleum Inspector - San Juan, Puerto Rico
Bureau Veritas —San Juan, PR
- Full-time
- Basic math
- High school diploma or GED
- Driver's License
Quality Technician, Energy Remanufacturing
Tesla —Vega Alta Municipio, PR
- Full-time
- English
- Mid-level
- Assembly
QUALITY ASSURANCE SPECIALIST
MENTOR TECHNICAL GROUP CORP —Carolina, PR
- Mid-level
- 3 years
- Continuous improvement
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Senior Manager Quality Assurance – Major Deviations Lifecycle Team
Amgen —Municipio de Juncos, PR
- Doctoral degree
- Master's degree
- High school diploma or GED
- Disability insurance
- Health insurance
Manager, Delinquency Management (QC & Operations)
Oriental Bank in San Juan —Bayamón, PR
- Full-time
- Hybrid work
- Spanish
- Microsoft Outlook
- English
Asistente de Técnico de Pruebas, Ajuste y Balanceo (TAB)
Scientific Safety Alliance —Bayamón, PR
- Full-time
- 401(k)
Quick Apply
USACE Quality Control Manager
Kundlas Consulting Group LLC —San Juan, PR
- Management
- Writing skills
- Engineering
Quick Apply
Quality Assurance Technician
Cooling Systems Caribe —Aibonito, PR
- From $13 an hour
- Full-time
- Entry level
- Paid training
- Health insurance
Quick Apply
2d
Designated Inspector (Engineer)
Custom Group, LLC. PR —Guaynabo, PR
- $45,458.91 - $50,359.12 a year
- Full-time
- Spanish
- Microsoft Excel
- Construction site
- Health insurance
- Dental insurance
Quick Apply
Inspector (PE)
Benitez, Ramos and Associates LLC —San Juan, PR
- From $1 an hour
- Full-time
- Civil engineering
- Construction site
- 5 years
- Health insurance
- Dental insurance
Quick Apply

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quality control jobs near san juan pr

Quality Assurance Specialist - GMP Manufacturing

Pinnaql, Inc
San Juan, PR

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Job Details

Full-time | Contract
$32.48 - $40.83 an hour
14 days ago

Qualifications

Spanish
Microsoft Excel
Database systems
Investigations regulatory compliance
Document control experience within pharmaceutical industry
Preventive action implementation
Production deviation management
Corrective and preventive actions (CAPA)
English
GMP
Internal investigations
Project management experience in manufacturing
Trend analysis
Manufacturing facility experience
Production validation processes
Quality risk management
Pharmaceutical company experience
Compliance documentation
Data interpretation
Organizational skills
Leading team collaboration initiatives
Regulatory/legal compliance standards in production
Biomedical regulatory compliance
Managing projects
Test Execution (Quality assurance practices)
Product quality assurance
Productivity software
Production batch record review
Commissioning phase involvement
Test validation method

Full Job Description

Position Overview

We are seeking a highly motivated and experienced QA Specialist to support Quality Assurance activities within a GMP-regulated manufacturing environment. This position will provide hands-on, on-the-floor Quality support and ensure manufacturing operations, documentation, processes, and systems comply with applicable cGMP requirements, company procedures, and quality standards.

The ideal candidate will have strong experience in pharmaceutical manufacturing, Quality Systems, deviations, CAPA, change control, validation, and compliance, along with the ability to work effectively with cross-functional teams.

Key Responsibilities

Provide on-the-floor Quality Assurance support for GMP manufacturing operations.
Review, approve, and track GMP processes, procedures, testing methods, manufacturing documentation, and quality records.
Perform and support batch record review, including electronic batch records (EBR) and manufacturing execution systems (MES).
Work with quality and business systems including SAP, EDMQ, DQMS, TrackWise, and MES/EBR platforms.
Review and support investigations, deviations, CAPAs, change controls, and validation activities.
Participate in on-the-floor deviation triage and ensure quality events are properly initiated, documented, investigated, and closed in accordance with procedures.
Ensure production records, testing results, and other GMP documentation are complete, accurate, and compliant with approved procedures.
Evaluate proposed changes for potential impact to product quality and ensure appropriate quality assessments are completed.
Support and provide Quality oversight for commissioning, qualification, validation, and other GMP projects.
Support validation activities for GxP computerized systems, including review and approval of validation documentation, risk assessments, test scripts, and qualification protocols and reports.
Support development and review of validation documentation such as Validation Master Plans, IQ, OQ, PQ, risk assessments, GxP assessments, protocols, test scripts, and summary reports.
Serve as a Quality representative for New Product Introduction (NPI) and other complex projects.
Collaborate closely with Manufacturing, Quality Control, Quality Systems, Process Development, Validation, Engineering, Warehouse, Facilities, Environmental, and other departments.
Participate in and lead continuous improvement initiatives designed to improve quality, compliance, and manufacturing processes.
Support internal and external audits and regulatory inspections, including serving as a Quality Unit representative when required.
Provide quality and compliance guidance to project teams and management.
Identify and evaluate compliance risks and recommend appropriate corrective actions.
Monitor and evaluate quality data, trends, and performance indicators to identify potential risks and improvement opportunities.
Ensure assigned GMP and quality training is completed and current before performing applicable activities.
Work independently while effectively communicating with employees and management at all organizational levels.
Maintain a strong focus on product quality, patient safety, regulatory compliance, and data integrity.

Required Qualifications

Bachelor's degree in a scientific, engineering, pharmaceutical, or related discipline.
4+ years of directly related experience in Quality Assurance, Quality Systems, pharmaceutical manufacturing, validation, or a closely related GMP environment.
Strong knowledge of cGMP/GMP requirements and pharmaceutical manufacturing processes.
Hands-on experience with deviations, CAPA, change control, investigations, and quality systems.
Experience supporting manufacturing operations in a GMP-regulated pharmaceutical, biotechnology, medical device, or life sciences environment.
Experience with batch records and manufacturing documentation, preferably including electronic batch records (EBR) and MES.
Experience with quality systems such as TrackWise, SAP, EDMQ, DQMS, or similar platforms.
Experience with commissioning, qualification, and validation activities.
Knowledge of GxP computerized systems validation/quality assurance, including validation protocols, risk assessments, test scripts, and validation reports.
Strong understanding of manufacturing, distribution, Quality Assurance, Quality Control, validation, and process development activities.
Ability to evaluate compliance issues and quality risks and determine appropriate actions.
Strong project management and organizational skills.
Ability to lead and influence cross-functional teams.
Strong analytical and data-trending skills.
Excellent written and verbal communication skills.
Strong presentation, facilitation, negotiation, and interpersonal skills.
Ability to work independently and effectively collaborate with employees at all organizational levels.
Strong proficiency with Microsoft Office applications, including Word, Excel, PowerPoint, and database applications.
Ability to interact professionally with regulatory agencies, auditors, and external partners.
Bilingual English and Spanish proficiency, both written and verbal, is required.

Preferred Qualifications

Experience in pharmaceutical or biotechnology manufacturing.
Experience supporting New Product Introduction (NPI) activities.
Experience working directly with manufacturing and production teams in an on-the-floor QA capacity.
Experience with computerized systems validation (CSV) or Computer System Quality Assurance (CSQA).
Experience with medical device quality systems is a plus.
Consulting or project-based Quality experience is a plus.
Experience supporting regulatory inspections and customer or internal audits.
Knowledge of 21 CFR, FDA regulations, data integrity, and other applicable GxP requirements.

Pay: $32.48 - $40.83 per hour

Work Location: In person

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Refine Your Search

quality control jobs in san juan pr

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