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:

• Supports the client's site GMP buildings Environmental Monitoring Process
• Generates Environmental Monitoring and Critical Utilities trend reports
• Participates and or Leads Risk Assessments to evaluate sampling sites for routine monitoring of GMP areas
• Provides assessments to change control records, deviations, audit processes that need support form the Environmental Control perspective
• Participate in forums such as the Environmental Control Network, Aseptic Council and or Contamination Control Network as assigned
• Attends client's GMP Buildings Quality system forums and or Management Review meetings to present environmental and critical utilities data and recommend actions based on the data evaluation
• Ensures that facilities, equipment, materials, organization, processes, procedures, and products comply with cGMP practices and other applicable regulations
• Supports Continuous Improvement initiatives, programs, and projects
• Collaborates cross functionally as needed to ensure the Quality Management System processes are performed in alignment with established procedures
• Alerts senior management of quality, compliance, supply, and safety risks
• Supports internal/external audits and inspections as needed

Qualifications:

• Bachelor's in sciences with concentration in any science discipline such as Engineering, Biology, Chemistry, Physis, Computer, etc
• Experienced in Quality Systems, including Deviations, Change Controls, CAPAs, and GMP documentation management.
• Quality Professional with experience in Validation, Commissioning, and Qualification (IQ/OQ/PQ) of manufacturing equipment and laboratory instrumentation, including functional testing.
• Strong expertise in Technical Writing and preparation, review, and approval of GMP technical documentation, including validation reports, technical reports, procedures, protocols, and forms.
• Strong understanding of cGMP, FDA regulations, and industry best practices for validation and quality compliance.