Specialist Quality Assurance

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:

• Perform one or more of the following duties and responsibilities in support Quality Assurance program under minimal supervision.
• Review and approve product MPs.
• Approve process validation protocols and reports for manufacturing processes.
• Release of sanitary utility systems.
• Represent QA on NPI team.
• Designee for QA manager on local CCRB.
• Support Automation activities.
• Review and approve EMS/BMS alarms.
• Approve NC investigations and CAPA records. Approve change controls.
• Strong knowledge of and experience with processes involved in manufacturing and distribution, QA, QAL, validation and process development.
• Demonstrate ability to interact with regulatory agencies.

Qualifications:

• Bachelor's degree 
• Five (5) years of directly related experience.
• Experience in batch record review, DAI process and to be familiar with in PASx/MES application, MAXIMO, SAP and LIMS
• Quality Professional with Manufacturing Process Audit and Batch Record Review experience.
• Knowledge or to be familiar with in PASx/MES application, MAXIMO, SAP and LIMS.
• Available for non standard shift which includes nights and weekends.
• Mon/Tue then Fri/Sat/Sun on alternate weeks from 5:00am to 5:30pm or from 5:00pm to 5:30am