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LL03-120324 Quality Assurance Specialist
Validation & Engineering Group, IncJuncos, 077Hace más de 30 días
Descripción del trabajoReview 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. 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. 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. 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. 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. 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. Bachelor’s degree in Biology, Chemistry, Biotechnology, or related field (Master’s preferred). 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. 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. 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. Reports findings and recommendations to Quality Management. Actively participates in audits and contributes to continuous improvement initiatives.
Department : Field - LL Location : Juncos, 077
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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 :
New Product Introduction :
Filling and Formulations :
Validation Support :
Quality Systems Management :
Continuous Improvement :
Qualifications
Education :
Experience :
Skills and Competencies :
Work Environment
Additional Information
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Quality Specialist • Juncos, 077
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