Overview
Quality Assurance Specialist Jobs in Bedford, MA at Planet Pharma
Title: Quality Assurance Specialist
Company: Planet Pharma
Location: Bedford, MA
Quality System Support: Assist in the development, implementation, and maintenance of the quality management system (QMS).
Ensure compliance with relevant regulatory requirements, including FDA, EMA, and other global agencies.
Documentation Control: Manage document control processes, including document creation, review, approval, distribution, and archival.
Maintain and update quality documents, standard operating procedures (SOPs), and records.
Audits and Inspections: Support internal and external audits, inspections, and assessments by regulatory authorities or third-party organizations.
Coordinate audit preparations and responses, ensuring timely closure of audit findings.
Training and Compliance: Provide training on quality procedures and ensure that employees are knowledgeable and compliant with established quality standards.
Monitor and track compliance metrics.
Non-Conformance Management: Investigate and assess non-conformances, deviations, and incidents.
Collaborate with cross-functional teams to implement corrective and preventive actions (CAPAs).
Risk Management: Assist in risk assessments and risk management activities.
Identify and assess potential risks and recommend mitigation strategies.
Continuous Improvement: Participate in quality improvement initiatives and projects to enhance processes and systems.
Promote a culture of continuous improvement and quality excellence.
Quality Reporting: Prepare and maintain quality reports, metrics, and key performance indicators (KPIs).
Communicate quality performance to management and stakeholders.
Qualifications:
Bachelor’s degree in a relevant scientific field, life sciences, or related discipline.
Experience in quality assurance or quality control within the pharmaceutical, biotechnology, or rare disease industry
Strong knowledge of regulatory requirements (FDA, EMA, ICH) and quality standards.
Excellent attention to detail, analytical, and problem-solving skills.
Proficiency in document control and quality management systems.
