What are the responsibilities and job description for the QA Specialist position at The Steely Group?
QA Specialist
- Pay Rate:$43-$45 per hour
- 10 month contract to conversion/extensions
- Bedford, MA
Responsibilities:
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.
Requirements / Qualifications:
- Bachelor's degree in a relevant scientific field, life sciences, or related discipline.
- Minimum of 2 years of 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. Effective communication and interpersonal abilities.
- Certification in Quality Assurance or related field is a plus.
Salary : $43 - $45
