Job Description

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:

• Support and oversee Quality Systems activities within manufacturing operations
• Investigate and document deviations, non-conformances, and quality events
• Ensure compliance with company procedures and quality standards
• Collaborate with Manufacturing and Quality teams to support continuous improvement initiatives
• Review and maintain quality documentation and records
• Assist in audits, inspections, and corrective action follow-up activities
• Promote a safe and compliant work environment

Qualifications:

• Bachelor’s Degree required
• Fully bilingual (English & Spanish)
• Minimum of 3 years of experience in: Quality Systems, Deviations and Manufacturing environments
• Must have management and supervisor experience
• Quality Professional with Manufacturing Process Audit and Batch Record Review experience.
• Ability to evaluate compliance issues.
• Able to 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.
• Strong organizational and communication skills
• Available to work administrative shift
• Support 2nd shift if needed

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.