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:        

　　Responsible for providing Quality oversight to ensure that operations products are manufactured, tested, stored, and distributed according to current Good Manufacturing Practices (cGMP), Good Distribution Practices (GDP) and other applicable regulations.

　　Collaborates cross functionally as needed to ensure the Quality Management Approves controlled documents, including Standard Operating Procedures, Reports, Validation Protocols, Validation Reports, Electronic Master Batch Records, etc.

　　Provides quality oversight for quality records including deviations/CAPAs, technical change controls, work orders, alarms and Process Monitoring Assessment Forms assuring adherence to procedural requirements and confirming assessments and evaluations of different partners are complete and accurate.

　　May act as the representative of QA in Quality Risk Management activities, ensuring alignment with corporate policies such as pFMEA, QRAES, and Computer system compliance.

　　On the floor presence and quality oversight, electronic batch record review, review and approval of GMP documentation, quality support in electronic batch record creation, and quality approval of deviations & CAPA records, if applicable.

　　Responsibilities will include evaluation of compliance issues, providing recommendations, and assuring progress of process and records to completion.

　　Qualifications:

　　Educated in a science field with 5 years of experience in GMP/GCP operations or similarly regulated industry.

　　Fluent in English and Spanish, including writing.

　　Experience in review/approval of batch record reviews, including electronic batch records.

　　Review and approve product MPs.

　　Problem solving skills.

　　Risk Assessment

　　Strong leadership capabilities and experience applying GMP requirements in an operational setting.

　　EMS/BMS alarms.

　　NC investigations and CAPA records.

　　Change controls.

　　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.

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