Overtime: 6 overtime days (3 FTE only) on Sunday shifts during July/August.
Job Description:
We are seeking a highly skilled Specialist in QA Quality Systems and Distribution with a strong background in biotech and experience using Veeva Quality Management Systems (QMS). This role will play a critical part in ensuring compliance and efficiency within our quality systems and distribution processes.
Responsibilities:
Quality Systems Management: Oversee and maintain the company's quality management system, ensuring compliance with regulatory requirements (e.g., FDA, EMA) and industry standards (e.g., GMP, GDP).
Documentation Control: Manage documentation processes, including document creation, review, approval, and archiving, utilizing Veeva Vault or similar document management platforms.
Change Control: Facilitate the change control process, including assessing change requests, implementing changes, and ensuring appropriate documentation and communication.
CAPA Management: Lead corrective and preventive action (CAPA) activities, including investigation, root cause analysis, and implementation of corrective actions to address quality issues and prevent recurrence.
Training Management: Coordinate training activities for quality systems and procedures, ensuring employees are adequately trained and compliant with applicable regulations.
Audit Readiness: Prepare for and support internal and external audits, including conducting mock audits, preparing documentation, and facilitating audit responses and corrective actions.
Distribution Compliance: Ensure compliance of distribution activities with regulatory requirements and internal quality standards, including transportation, storage, and handling of biotech products.
Continuous Improvement: Identify opportunities for process improvements within quality systems and distribution processes, implementing best practices to enhance efficiency and effectiveness.
Requirements:
Experience: Minimum 3-5 years of experience in quality assurance within the biotech industry, with a focus on quality systems and distribution.
Veeva Experience: Proficiency in using Veeva Quality Management Systems (QMS) or similar electronic document management systems is required.
Regulatory Knowledge: Understanding of FDA regulations, EU regulations, and international quality standards relevant to biotech manufacturing and distribution.
Attention to Detail: Strong attention to detail and accuracy in documentation and compliance activities, with a commitment to maintaining high-quality standards.
Communication Skills: Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams and external stakeholders.
Problem-Solving Abilities: Demonstrated ability to analyze complex issues, identify root causes, and implement effective solutions.
Project Management: Strong organizational and project management skills, with the ability to prioritize tasks, meet deadlines, and manage multiple projects simultaneously.
Team Player: Collaborative mindset with a willingness to work in a dynamic and fast-paced environment, contributing to the success of the team and the organization.
Education: Bachelor's degree in a relevant scientific discipline or equivalent experience in biotech quality assurance.