Quality Compliance Analyst: Drive GMP Excellence

CooperVision; Juana Díaz (PR); On-site; USD 55,000 - 85,000; Full time

Job summary

CooperVision is seeking a Quality Auditor to conduct audits ensuring adherence to specifications, procedures, and regulatory compliance. You will support Quality System activities, manage NCRs, and help drive CAPA and QI initiatives in a fast-paced environment.

The ideal candidate holds a Bachelor's in a related field or equivalent document control experience, with strong English/Spanish communication and proficiency in Word/Excel/PowerPoint, and willingness to travel as needed.

Qualifications

• Knowledge of GMP’s/QSR and regulatory requirements.
• Excellent oral and written communication in English and Spanish.
• Service oriented with ability to coordinate, evaluate and inspect product.
• Computer literacy in MS Word, Excel, and PowerPoint.
• High analytical capacity and professional judgment.

Responsibilities

• Perform lot document spot screenings and routine monitoring audits.
• Generate NCRs for non-conforming materials and initiate resolution.
• Ensure compliance with laws and regulations and quality KPIs.
• Assist in defining tactics for quality metrics and approve quality documents.
• Provide training and support for QI activities and CAPA completion.
• Participate in CAPA reports and investigations, and monitor NCR actions.
• Possibility of travel as required by the role.

Skills

GMP/QSR knowledge

English/Spanish

Coordination

Product inspection

MS Word

Excel

PowerPoint

Interpersonal skills

Self-motivated

Education

Bachelor's degree in business or science

Document control experience

Tools

MS Word

Excel

PowerPoint

Job description

CooperVision is seeking a Quality Auditor to conduct audits ensuring adherence to specifications, procedures, and regulatory compliance. You will support Quality System activities, manage NCRs, and help drive CAPA and QI initiatives in a fast-paced environment.

The ideal candidate holds a Bachelor's in a related field or equivalent document control experience, with strong English/Spanish communication and proficiency in Word/Excel/PowerPoint, and willingness to travel as needed.