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LL03-120324 Quality Assurance Specialist

LL03-120324 Quality Assurance Specialist

Validation & Engineering Group, IncJuncos, 077
Hace más de 30 días
Descripción del trabajo

Department : Field - LL Location : Juncos, 077

START YOUR APPLICATION

Validation & Engineering Group, Inc. (V&EG) is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas : Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.

We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position :

  • QA Specialist

The QA Specialist ensures compliance with quality systems, oversees batch record reviews, and supports the implementation of new products and formulations. This role involves working closely with cross-functional teams to ensure manufacturing and validation processes adhere to regulatory requirements, continuous improvement, with a specific focus on electronic batch records (eBR), filling formulations, and quality systems.

Key Responsibilities

Batch Record Review :

  • Review and approve batch records (both paper and eBR) to ensure compliance with GMP and internal standards.
  • Collaborate with manufacturing and production teams to resolve discrepancies in batch documentation.
  • Provide input on the design and implementation of eBR systems to improve efficiency and compliance.
  • New Product Introduction :

  • Support quality oversight during the development and implementation of new products, ensuring compliance with regulatory and company standards.
  • Participate in risk assessments and establish quality requirements for new processes and formulations.
  • Develop quality-related documentation for new product launches, including standard operating procedures (SOPs) and validation protocols.
  • Filling and Formulations :

  • Ensure quality oversight during filling and formulation processes, verifying adherence to established protocols and specifications.
  • Investigate and address deviations or non-conformances related to filling and formulations.
  • Monitor in-process controls and critical quality attributes to ensure product consistency.
  • Validation Support :

  • Assist in validation activities, including process validation, equipment qualification (IQ / OQ / PQ), and cleaning validation.
  • Review and approve validation protocols and reports.
  • Ensure validation documentation is complete, accurate, and audit-ready.
  • Quality Systems Management :

  • Maintain and improve quality systems, including CAPA, change control, deviations, and risk management.
  • Support regulatory inspections and audits, providing required documentation and addressing findings.
  • Ensure compliance with FDA, EU GMP, and other regulatory guidelines.
  • Continuous Improvement :

  • Identify areas for process improvement in quality assurance workflows and systems.
  • Collaborate with cross-functional teams to implement best practices and corrective actions.
  • Provide training and guidance on quality systems and regulatory requirements to staff.
  • Qualifications

    Education :

  • Bachelor’s degree in Biology, Chemistry, Biotechnology, or related field (Master’s preferred).
  • Experience :

  • 3–7 years of experience in Quality Assurance within the biotech or pharmaceutical industry.
  • Hands-on experience with electronic batch records (eBR) systems and manual batch records.
  • Knowledge of filling formulations and manufacturing processes in a biotech environment.
  • Experience with quality systems, including CAPA, change control, and deviations.
  • Familiarity with validation processes and regulatory inspections.
  • Skills and Competencies :

  • Thorough understanding of Continuous improvement, GMP and regulatory requirements (FDA, ICH, EU GMP).
  • Strong problem-solving and analytical skills.
  • Proficiency in quality system software and eBR platforms.
  • Excellent attention to detail and ability to manage multiple priorities.
  • Strong communication and collaboration skills.
  • Work Environment

  • Primarily works in office and cleanroom environments.
  • May require standing or walking for extended periods in manufacturing areas.
  • Some travel may be required for audits, training, or project implementation.
  • Additional Information

  • Reports findings and recommendations to Quality Management.
  • Actively participates in audits and contributes to continuous improvement initiatives.
  • START YOUR APPLICATION

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    Quality Specialist • Juncos, 077

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