Specialist QA

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:

• Review and approve product MPs. Approve process validation protocols and reports for manufacturing processes.
• Request Quality on incident triage team.
• Approve Environmental Characterization reports. Release of sanitary utility systems.
• Approve planned incidents. Represent QA on NPI team.
• Lead investigations. Lead site audits. Own site quality program procedures.
• Designee for QA manager on local CCRB. Review Risk Assessments.
• Support Automation activities. Support facilities and environmental programs.
• Review and approve Work Orders.
• Review and approve EMS/BMS alarms.
• Approve NC investigations and CAPA records. Approve change controls. Provide lot disposition and authorize lots for shipment.
• Perform Trackwise system queries, deviations. Participate in triage process
• Perform oversight of the process and procedures/GMP tasks
• Manage Change Controls and deviations for review and approval as QA contact
• Work with operations to resolve basic compliance discrepancies

Qualifications:

• Bachelor's degree and 5 years of directly related experience
• Knowledge in Validations and Laboratory area and equipment
• Fully Bilingual in English and Spanish.
• Validated skill in working independently and to optimally interact with all levels throughout the organization.
• 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.
•  Advanced data trending and evaluation.
• Ability to evaluate compliance issues.