Job Description
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:
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.
...lives of individuals and the businesses we serve. To learn more, please visit Position Overview: As a Sales Executive within our CBS Division, you will be responsible for identifying and onboarding new clients while overseeing project management from initiation to completion...
...coordinated care environment in avalue-basedrelationship environment Knowledge of Medicare guidelines and coverage Knowledge of HEDIS quality indicators Bilingual (English/Spanish) is preferred Additional Information ~ Competitive annual base salary + bi-...
...Supplemental Health Care is seeking a LPN / LVN School Nurse for a local contract job in Poplar Bluff, Missouri. Job Description & Requirements ~ Specialty: School Nurse ~ Discipline: LPN / LVN ~ Start Date: ASAP ~ Duration: 13 weeks ~37 hours per week...
Title Insurance Underwriter-Central TeamInvestors Title Insurance CompanyLocation: Wilmington, NC (in office)Type: Full-TimeApplication Deadline: May 16, 2025Overview Investors Title Insurance Company is seeking a detail-oriented and organized Title Insurance Underwriter...
...Clearance: Secret Posted Date: 6/25/2025 Category: Engineering-Software Employment Type: Full Time Hiring Company: General Dynamics Mission Systems, Inc. Basic Qualifications Bachelor's degree or equivalent in a related specialized area is required...