Facilities Management (FM) Quality /Compliance Staff Engineer
Johnson & Johnson
8 days ago
On-site
Jacksonville, FL
Operations
Job Description:
Facilities Management (FM) Quality /Compliance Staff Engineer (Jacksonville, Florida)
Key Responsibilities:
- Support development and management of GMP compliance systems, including site nonconformance management:
- Review/approve nonconformance investigations and associated documentation
- Manage entry of nonconformance records into the appropriate electronic system
- Track investigations from initiation through closure; advise personnel on status, CAPA, and commitments
- Coordinate investigations to identify root causes and appropriate corrective actions
- Approve closure of nonconformance investigations upon completion of investigations and corrective actions
- Support development and management of document management systems:
- Administer the site Electronic Document Management System (EDMS)
- Develop and apply EDMS systems and procedures
- Manage document control for SOPs and other GMP-regulated documents; support Documentation Control personnel as needed
- Provide training and support to users
- Generate reports and metrics as needed
Qualifications:
- Education: Bachelor’s (or equivalent) degree in a Scientific/Technical subject area (required)
- Required Experience/Skills:
- 4+ years related work experience
- Quality, manufacturing, validation, or compliance role experience in a GMP-regulated industry
- Knowledge of FDA/EMEA regulatory requirements for Medical Devices and/or pharmaceuticals; ability to apply GMP and relevant FDA/international guidelines
- Preferred:
- Auditing experience for external suppliers/contractors/vendors
- Experience developing/evolving GMP systems and/or startup experience
- Medical Device/pharmaceutical quality/manufacturing/validation/compliance experience
- Other: General knowledge of facility support services (GMP cleaning, cafeteria regulatory compliance, pest control, audit readiness, critical-to-quality preventative maintenance); up to 10% travel
Facilities Management (FM) Quality /Compliance Staff Engineer (Jacksonville, Florida)
Key Responsibilities:
- Support development and management of GMP compliance systems, including site nonconformance management:
- Review/approve nonconformance investigations and associated documentation
- Manage entry of nonconformance records into the appropriate electronic system
- Track investigations from initiation through closure; advise personnel on status, CAPA, and commitments
- Coordinate investigations to identify root causes and appropriate corrective actions
- Approve closure of nonconformance investigations upon completion of investigations and corrective actions
- Support development and management of document management systems:
- Administer the site Electronic Document Management System (EDMS)
- Develop and apply EDMS systems and procedures
- Manage document control for SOPs and other GMP-regulated documents; support Documentation Control personnel as needed
- Provide training and support to users
- Generate reports and metrics as needed
Qualifications:
- Education: Bachelor’s (or equivalent) degree in a Scientific/Technical subject area (required)
- Required Experience/Skills:
- 4+ years related work experience
- Quality, manufacturing, validation, or compliance role experience in a GMP-regulated industry
- Knowledge of FDA/EMEA regulatory requirements for Medical Devices and/or pharmaceuticals; ability to apply GMP and relevant FDA/international guidelines
- Preferred:
- Auditing experience for external suppliers/contractors/vendors
- Experience developing/evolving GMP systems and/or startup experience
- Medical Device/pharmaceutical quality/manufacturing/validation/compliance experience
- Other: General knowledge of facility support services (GMP cleaning, cafeteria regulatory compliance, pest control, audit readiness, critical-to-quality preventative maintenance); up to 10% travel