QA Compliance Specialist

JLL • Gurabo, PR

1d • Onsite

About The Position

JLL is hiring a Quality Compliance Specialist to support quality and compliance programs for a Facilities team and its subcontractors at an FDA-regulated manufacturing site in Gurabo, Puerto Rico. The role ensures work is performed in accordance with SOPs, applicable industry regulations, current practices, and contractual requirements. It is on-site, Monday through Friday, 8:00 a.m. to 5:00 p.m., with an indefinite-term contract.

The specialist develops, implements, supports, and manages quality programs, including non-conformance investigations, CAPAs, training compliance, vendor qualifications, quality agreements, audits, self-assessments, document management, and change control. The role partners with site and client personnel, leads the design and ongoing sustainability of compliance programs, supports audits, prepares documents and training materials, and ensures work is properly documented. It also manages quality and compliance performance measurements, submits program status reports, leads staff through clear expectations and feedback, and communicates quality requirements and regulatory changes to vendors and service providers.

The position requires a relevant bachelor's degree or equivalent and three years of experience in similar roles. Candidates must be authorized to work in the United States without sponsorship; visa sponsorship is not provided.

Requirements

• Bachelor's degree or equivalent in a relevant field such as quality management, business administration, or a related discipline.
• Three years of experience in similar roles.
• Strong background in technical documentation.
• Ability to investigate, recognize, and diagnose trends and patterns.
• Experience with Root Cause Analysis and related tools.
• General understanding of cGMPs as they relate to maintenance and repairs of facilities, utilities, and equipment used in manufacturing drug products.
• Experience working in an FDA-regulated manufacturing facility in a quality assurance or quality control capacity.
• Understanding of FDA regulations, including 21 CFR Parts 210 and 211.
• Strong commitment to quality assurance and willingness to help develop a quality-first culture on site.
• Knowledge of Quality Engineering techniques, CMMS systems, and Quality Management Systems.
• Ability to communicate effectively with technical, quality assurance, and other personnel.
• Proficiency in Microsoft Office Suite programs, including Word and Excel, and a QMS system such as COMET.
• Must be authorized to work in the United States without sponsorship; visa sponsorship is not provided.

Responsibilities

• Develop, implement, support, and manage quality programs, ensuring program deliverables meet or exceed expectations.
• Build effective relationships with account and client personnel to promote confidence, forward planning, and best practices.
• Provide management and leadership for the design, development, implementation, and sustainability of quality and compliance programs.
• Collaborate with the site team and share and reapply learnings, successes, and best practices.
• Support non-conformance investigations, CAPAs, training compliance, vendor qualifications, quality agreements, audits, self-assessments, document management, and change control.
• Help ensure Facilities team and subcontractor work complies with SOPs, applicable regulations, current practices, and contractual requirements.
• Perform or support audits and prepare documents and training materials for site staff.
• Interface with client quality personnel to ensure client requirements are followed and work is documented and recorded appropriately.
• Manage and report quality and compliance critical and key performance measurements.
• Develop and submit status reports related to the Quality Program.
• Lead staff by communicating expectations and accountabilities and providing performance feedback for continuous improvement.
• Provide information and guidance to vendors, account staff, and service providers so quality expectations and industry regulatory changes are communicated and followed.
• Perform other duties and tasks as deemed necessary.

Benefits

• 401(k) plan with matching company contributions.
• Comprehensive medical, dental, and vision care.
• Paid parental leave at 100% of salary.
• Paid time off and company holidays.
• Early access to earned wages through Daily Pay.
• Supportive culture and a comprehensive benefits package prioritizing mental, physical, and emotional health.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level