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JT619 - SPECIALIST QA

Quality Consulting Group

Juncos, Juncos, Puerto RicoJobNo compensation foundTracked 1w agoSeen in employer's feed 2 days ago
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At a glance

Compensation
No compensation found
Location
Juncos, Juncos, Puerto Rico
Work Authorization
Not specified

Requirements

Credentials this posting asks for.

Bachelor's degree

Job overview

Quality Consulting Group is hiring a JT619 - SPECIALIST QA. Quality Consulting Group seeks a talented, highly motivated QA Specialist to join a enthusiastic team, contributing to world‑class manufacturing in the pharmaceutical, biotech, medical device, and manufacturing sectors across Puerto Rico and the USA.

Key focus areas include Review, approve, and maintain manufacturing process documentation in compliance with cGMP requirements., Review, approve, and ensure accuracy, completeness, and traceability of GMP documentation including protocols, reports, investigations, and quality records., and Approve process validation protocols and reports, including PPQs and cleaning validation documentation..

Important skills include cGMP, GMP Documentation, Process Validation, PPQ, Cleaning Validation, and Incident Triage.

Skills & qualifications

RequiredNice to have

Skills

cGMPGMP DocumentationProcess ValidationPPQCleaning ValidationIncident TriageRisk AssessmentEnvironmental MonitoringSanitary Utility SystemsNew Product IntroductionRoot Cause AnalysisCAPA DevelopmentSite AuditsChange Control Review BoardAutomation SystemsAseptic ManufacturingChange ControlFATValidationManufacturing ProcessesEquipment QualificationComputerized SystemsBiological Processes

Qualifications

BS in Science Engineering Physics Biology Chemistry or Related Fields5+ Years Experience in Highly Regulated EnvironmentManufacturing and Laboratory ExperienceExperience in Quality and ComplianceExperience With Validation Protocols and ReportsExperience in Biological ProcessesStrong Knowledge of Aseptic Manufacturing ProcessesChange Control ExperienceProven Experience With NPI Change Control FATs Validation PPQs Cleaning ValidationDemonstrated Expertise in GMP Documentation Practices

Full job description

QUALITY CONSULTING GROUP, a leader in the pharmaceutical, biotech, medical devices, and manufacturing industry, is looking for a talented, highly motivated and enthusiastic to join our team. In this role, you’ll work with a highly enthusiastic team, contributing in a world-class manufacturing industry in Puerto Rico & USA.

Responsibilities:

  • Review, approve, and maintain manufacturing process documentation (MPs) in compliance with cGMP requirements

  • Review, approve, and ensure accuracy, completeness, and traceability of GMP documentation, including protocols, reports, investigations, and quality records

  • Approve process validation protocols and reports, including PPQs and cleaning validation documentation

  • Participate as Quality representative on incident triage teams, ensuring timely and compliant decision-making

  • Review and approve planned incidents, deviations, and nonconformances, ensuring appropriate risk assessment and documentation

  • Approve Environmental Characterization and environmental monitoring reports

  • Release and maintain compliance of sanitary utility systems

  • Represent Quality Assurance on New Product Introduction (NPI) teams

  • Lead and document investigations, root cause analyses, and CAPA development

  • Lead and support site audits, including internal, external, and regulatory inspections

  • Own, maintain, and continuously improve site quality program procedures

  • Serve as QA Manager designee on the local Change Control Review Board (CCRB)

  • Review and approve risk assessments and mitigation strategies

  • Support automation systems, including review of validation and change documentation

  • Support facilities, utilities, and environmental compliance programs

Qualifications:

  • Possess a BS in Science, Engineering, Physics, Biology, Chemistry or related fields.

  • Experienced working in biopharmaveutical industry, quality organization supporting deviations, validation reports, qualifications, investigations.

  • 5 years of experienced in a highly regulated environment.

  • Experience in Quality and Compliance, experience with validation protocols and reports for clean utilities, manufacturing processes, cleaning processes, equipment, computerized systems, change control records, deviations, etc.

  • Experience in biological processes

  • Strong knowledge and hands-on experience with Aseptic manufacturing processes

  • Change Control Experience

  • Proven experience with NPI, Change Control, FATs, Validation, PPQs, and Cleaning Validation

  • Manufacturing and laboratory experience required

  • Demonstrated expertise in GMP documentation practices, including protocol/report review, investigations, and regulatory submissions

  • Strong understanding of manufacturing, distribution, QA/QC/QAL, validation, and process development activities

  • 8hrs Monday to Friday (Administrative), available nonstandard as needed.

Quality Consulting Group, LLC is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.

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