The successful candidate will be a key contributor to the Quality team and instrumental to the success of clinical trials. We are a dynamic team with many opportunities to cross-train, expand capabilities, and learn new analytical techniques. The QA Specialist reports to the Director of Quality.
Responsibilities:
The Quality Assurance Specialist is responsible for ensuring compliance with regulatory standards and internal quality policies. They meticulously review and approve batch records, SOPs, and other documentation to guarantee accuracy and completeness. The specialist identifies areas for improvement, administers systems, and implements corrective actions to maintain high-quality standards. Additionally, they oversee the documentation of deviations, CAPAs (Corrective and Preventive Actions), and ensure that all processes align with Good Manufacturing Practices (GMP) and regulatory requirements.
Key Responsibilities:
The key responsibilities of a Quality Assurance Specialist include, but are not limited to:
Responsibilities:
Reviews and approves documentation such as batch records, standard operating procedures (SOPs), and production documents to ensure compliance with GMP standards
Supports Deviations, CAPA's and Change Controls
Maintains and improves paper-based quality systems
Assists with the qualification of suppliers and the evaluation of supplier performance
Perform onsite recording of QMS data (collect/scan/email/post records)
Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, company policies, operating procedures, and processes
The desired skills and qualities of a Quality Assurance Specialist:
BS/MS Degree (preferred in a scientific discipline)
1-4 years of experience in a GMP pharmaceutical setting
Broad understanding of cGMP, especially relating to documentation and systems.
Strong attention to detail and ability to meet deadlines.
Excellent interpersonal skills for effective communication with individuals, teams, and external organizations.
High level of professional integrity and trustworthiness with strong work ethics
Proficient with Microsoft Office, including Word, Excel, PowerPoint, and Outlook