QUALITY CONSULTING GROUP, a leader in the pharmaceutical, biotech, medical devices, and manufacturing industry, is looking for a talented, highly motivated and enthusiastic to join our team. In this role, you'll work with a highly enthusiastic team, contributing in a world-class manufacturing industry in Puerto Rico & USA. Responsibilities: You will perform review, approval and tracking of cGMP processes, procedures, testing (methods) in manufacturing, documents and records, batch record review, MES, EBR, SAP, Trackwise; including but not limited to Deviation's, CAPAs, and validations Actively engage in Continues Improvement initiatives, programs and projects Vigilant ensuring that changes that could potentially impact product quality are assessed according to procedures Certify that deviations from established procedures are investigated and documented per procedures Ensures that production records and testing results are complete, accurate, and documented according to written procedures and cGMP requirements To be successful, you will require strong collaboration and partnership cross functionally to ensure the Quality Management System processes are executed in accordance with established procedures Strategic advisor to senior management of quality, compliance, supply and safety risks Supports internal/external audits and inspections as part of the audit/inspection management team including acting as Quality unit representative as needed. Provides support and oversight of New Product Introduction (NPI) Qualifications: Bachelor's degree and 5 years of directly related experience Validated expertise in Quality Systems such as Non-Conformance, CAPA, and Change Control Experience in computer systems validation or computer systems quality assurance (medical device and/or consulting background Technical proficiency) Robust knowledge of and experience with processes involved in manufacturing and distribution, QA, QAL, and Process Development Experience with Validation of GxP applications, Validation Master Plan (IQ), Risk Assessment/GxP assessment, OQ, and PQ Protocols, Test Scripts, and Completion/Summary Reports approvals as per the compliance requirements Validated experience as Quality Contact for complex projects involving packaging, inspection, and new products Validated experience in Commissioning and Qualification. Must be available for 12 hours shifts (5:00am-5:30pm - 5:00pm-5:30am) Quality Consulting Group, LLC is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity,, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law. Powered by JazzHR
