QA Specialist – Validation, Compliance & Investigations

Inteldot; Juncos (PR); On-site; USD 70,000 - 100,000; Full time

Job summary

Inteldot is seeking an experienced Administrative Shift QA professional to support the Quality Assurance program. The role involves manufacturing, process validation, regulatory compliance, and QA activities under minimal supervision.

Key responsibilities include reviewing MPs, approving validation protocols, leading site audits, and coordinating cross-functional teams to ensure regulatory adherence and product quality. Strong communication and project management skills are essential.

Qualifications

• Experience with Change Control and QA
• Experience with validation and process development
• Ability to interact with regulatory agencies and audits
• Strong documentation and record-keeping skills
• Ability to lead cross-functional teams and projects
• Excellent written and oral communication skills

Responsibilities

• Review and approve product MPs
• Approve process validation protocols and reports
• Lead site audits and investigations
• Own QA site quality program procedures
• Review and approve changes and CAPA records
• Coordinate with regulatory agencies as needed

Skills

Project management

Cross-functional leadership

Communication (written and oral)

Facilitation and presentation

Independent work

Data trending and evaluation

Regulatory interaction

Quality assurance execution

Process validation

Negotiation skills

Education

Masters + 2 years related experience

Tools

MS Office

Job description

Inteldot is seeking an experienced Administrative Shift QA professional to support the Quality Assurance program. The role involves manufacturing, process validation, regulatory compliance, and QA activities under minimal supervision.

Key responsibilities include reviewing MPs, approving validation protocols, leading site audits, and coordinating cross-functional teams to ensure regulatory adherence and product quality. Strong communication and project management skills are essential.