Jll
JLL provides professional services in real estate and investment management worldwide.
Quality Specialist
Ensures cGMP compliance for pharma facility ops, audits, SOPs, training, QA.
Job Highlights
About the Role
The Quality Specialist position provides comprehensive quality‑assurance support for pharmaceutical facility operations, ensuring maintenance, warehouse and operations activities comply with company policies, client procedures, and FDA cGMP regulations. The role maintains the highest quality standards in regulated manufacturing environments, supports continuous‑improvement initiatives and works closely with facility management teams and client quality‑control personnel. • Execute quality compliance programs for cGMP manufacturing facilities and ensure full regulatory adherence. • Conduct facility self‑assessments and vendor/supplier audits to maintain quality standards. • Prepare and revise SOPs, change‑control documentation, investigations, and CAPAs. • Develop training materials for facilities maintenance and operations teams and maintain personnel qualification files. • Track and follow up on quality events with department managers to ensure resolution. • Support achievement of Key Performance Indicators outlined in Service Level Agreements. • Interface with client quality‑control personnel to ensure proper documentation and SOP adherence. • Develop and execute quality controls for warehousing and operations. • Train, mentor and develop JLL personnel in GMP, GDP, compliance and regulations.
Key Responsibilities
- ▸compliance programs
- ▸facility audits
- ▸sop management
- ▸training development
- ▸quality tracking
- ▸client interface
What You Bring
This full‑time, on‑site role is based in Apex, NC and does not offer visa sponsorship; candidates must be authorized to work in the United States without sponsorship. JLL encourages applicants who resonate with the description to apply even if they do not meet every requirement. • Bachelor’s degree in Engineering or equivalent experience. • Minimum 5 years experience in pharmaceutical, biotech, medical‑device or life‑sciences sectors under GMP regulations. • Minimum 4 years regulatory quality and statutory compliance experience. • Quality‑assurance experience in FDA‑regulated manufacturing facilities. • Strong knowledge of cGMP regulations as applied to maintenance and manufacturing equipment. • Proficiency with quality‑engineering techniques, CMMS systems and Quality Management Systems. • Advanced computer skills (Microsoft Word, Excel, PowerPoint) and SAP or similar ERP systems. • Excellent verbal and written communication skills and ability to resolve complex operational challenges. • Auditing experience in pharmaceutical or regulated manufacturing environments. • Experience with documentation control systems and change‑management processes. • Background in facility maintenance operations within pharmaceutical settings. • Knowledge of Quality Management Systems implementation and continuous‑improvement methodologies. • Experience developing training programs for technical teams. • Familiarity with client‑satisfaction survey processes and KPI management. • Self‑motivated, detail‑oriented work style and ability to work independently in dynamic teams. • Professional certifications in Quality, Regulatory Affairs or cGMP (e.g., ASQ, RAC).
Requirements
- ▸bachelor's
- ▸gmp
- ▸regulatory
- ▸cmms
- ▸sap
- ▸auditing
Benefits
JLL offers a supportive culture and a comprehensive benefits package that prioritizes mental, physical and emotional health, including retirement, healthcare, paid parental leave, paid time off, early wage access and more. • 401(k) plan with matching company contributions. • Comprehensive medical, dental and vision coverage. • Paid parental leave at 100 % of salary. • Paid time off and company holidays. • Early access to earned wages through Daily Pay.
Work Environment
Onsite