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.