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:

• Quality Assurance Specialist

The QA Specialist plays a critical role in ensuring that all biotechnology and pharmaceutical products meet regulatory standards and internal quality specifications. This role involves monitoring, auditing, and maintaining quality control processes throughout the product lifecycle, from research and development to production, testing, and distribution. The QA Specialist works to identify, investigate, and resolve quality issues, ensuring compliance with Good Manufacturing Practices (GMP), FDA regulations, and other applicable guidelines.

Key Responsibilities:

Quality Oversight:

• Ensure compliance with GMP, FDA, and other regulatory standards.
• Oversee quality systems for manufacturing, packaging, and testing.
• Collaborate with cross-functional teams to ensure product quality and process efficiency.

Documentation and Record Keeping:

• Review and approve quality-related documentation, including batch records, standard operating procedures (SOPs), deviations, change controls, and CAPAs (Corrective and Preventive Actions).
• Maintain accurate and up-to-date records of all QA activities.

Auditing and Inspections:

• Conduct internal and external audits to assess compliance with quality standards.
• Prepare for and participate in regulatory inspections and customer audits.
• Provide support during regulatory submissions, such as those for the FDA, EMA, or other regulatory bodies.

Quality Control:

• Monitor production processes to ensure adherence to quality standards.
• Investigate quality-related issues, deviations, and non-conformances, implementing appropriate corrective actions.
• Support continuous improvement initiatives in quality processes and procedures.

Validation and/or Product Release:

• Review and approve validation protocols or batch records for product release, ensuring that all critical quality attributes are met.

Risk Management:

• Conduct risk assessments to identify potential quality issues and propose mitigations.
• Support the implementation of risk-based approaches in quality management processes.

Training and Development:

• Stay updated on industry trends, regulatory changes, and new quality assurance techniques.

Qualifications:

• Bachelor’s degree in Life Sciences, Biotechnology, Pharmaceutical Sciences, or a related field.
• 5+ years of experience in quality assurance in a biotechnology, pharmaceutical, or life sciences environment.
• In-depth knowledge of GMP, FDA regulations, and quality systems in the biotech/pharmaceutical industry.
• Strong problem-solving and analytical skills.
• Excellent written and verbal communication skills.
• Proficiency in quality management software and systems (e.g., LIMS, QMS).

Preferred Qualifications:

• Experience with biological product manufacturing.
• Familiarity with quality assurance in a clinical setting.
• Certification in Quality Assurance (e.g., ASQ certification).

Key Competencies:

• Attention to detail.
• Strong organizational skills.
• Ability to work independently and as part of a team.
• Critical thinking and decision-making.