QA Compliance Specialist

JLL•Gurabo, PR

1d•Onsite

About The Position

JLL is hiring a QA Compliance Specialist for an on-site role in Gurabo, Puerto Rico. The position is responsible for developing, implementing, supporting, and managing quality and compliance programs for facilities work and subcontractors, ensuring work follows standard operating procedures, applicable industry regulations, current practices, and contractual requirements. Programs include non-conformance investigations, corrective and preventive actions (CAPAs), training compliance, vendor qualifications, quality agreements, audits, self-assessments, document management, and change control. The specialist will lead the design, development, implementation, and ongoing operation of quality and compliance programs; support audits; prepare documents and training materials; and coordinate with client quality personnel to ensure requirements are followed and work is properly documented. The position also manages and reports quality and compliance performance measures, prepares program status reports, communicates quality expectations and regulatory changes to vendors and service providers, and provides staff leadership and performance feedback. The schedule is Monday through Friday, 8:00 a.m. to 5:00 p.m. The contract type is indefinite-term. Visa sponsorship is not provided; candidates must be authorized to work in the United States without sponsorship.

Requirements

Bachelor's degree or equivalent in 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 apply to maintenance and repairs of facilities, utilities, and equipment used to manufacture 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 programs, including Word and Excel, and a QMS system such as COMET.
Must be authorized to work in the United States without visa sponsorship.

Responsibilities

Develop, implement, support, and manage quality programs to ensure program deliverables meet or exceed expectations.
Build relationships with account personnel 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 lessons learned, successes, and best practices.
Support quality programs, including non-conformance investigations, CAPAs, training compliance, vendor qualifications, quality agreements, audits, self-assessments, document management, and change control.
Ensure facilities work performed by the team and subcontractors complies with SOPs, industry 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 properly documented and recorded.
Manage and report quality and compliance critical and key performance measurements, and submit program status reports.
Lead staff by communicating expectations and accountabilities and providing performance feedback for continuous improvement.
Provide information and management to vendors, account staff, and service providers to communicate quality assurance expectations and changes to industry regulations.
Perform other duties and tasks as deemed necessary.