Quality Associate I (Technician) – Aibonito

Provide Quality support and oversight via direct staff supervision or process/area responsibilities. Identify and assess regulatory and quality risks in activities and processes according to regulatory agency rules and guidelines and quality practices. The incumbent leads ongoing, daily departmental operations. May include the supervision of assigned personnel in achieving defined quality goals in an efficient, accurate and timely manner; Develop plans to correct identified risks including areas of non-conformance, inform management and implement approved corrective action plans. Write, review, analyze and revise written Standard Operating Procedures (SOPs) and submit procedural changes as needed to meet Corporate, Divisional, Plant, Regulatory Requirements, etc. Support external assessments or audits. Assist with audits of various reports (Protocols, Qualifications, etc.)
Requisitos:
Associate degree in business/scientific discipline and one to three years of relevant. Must be able to work Thursday to Sunday 6am to 6pm. Strong interpersonal skills and great attention to detail are necessary. Must be a strong team player with good problem solving, and good verbal and written communication skills in English and Spanish. Must be able to handle multiple projects concurrently, have computer experience and have knowledge of FDA Regulations, Application of Good Laboratory Practices, and Application of Good Manufacturing Practices as appropriate. Temporary contract 25807