Specialist QA 35670

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 has over 15 years in the life sciences industry, with operations across Puerto Rico, the United States, Europe, and Japan. This is a great opportunity for one of our leading clients in Puerto Rico.

Administrative Shift

Job Description:

Under minimal supervision, support Quality Assurance program by performing a variety of key responsibilities in manufacturing, process validation, regulatory compliance, and quality assurance activities.

Requirements & Qualifications:

• Change Control
• Documentation Review
• Validation
• PPQ
• Project management skills.
• Strong organizational skills, including ability to follow assignments through to completion.
• Initiate and lead cross functional teams.
• Enhanced skills in leading, influencing and negotiating.
• Strong knowledge in area of expertise.
• Collaborate and coordinate with higher level outside resources.
• Strong knowledge of and experience with processes involved in manufacturing and distribution, QA, QAL, validation and process development.
• Demonstrate ability to interact with regulatory agencies.
• Strong word processing, presentation, database and spreadsheet application skills.
• Strong communication (both written and oral), facilitation and presentation skills.
• Strong skill in working independently and to effectively interact with various levels.
• Advanced data trending and evaluation.
• Ability to evaluate compliance issues

Functions:

• Review and approve product MPs.
• Approve process validation protocols and reports for manufacturing processes.
• Request Quality on incident triage team.
• Approve Environmental Characterization reports.
• Release of sanitary utility systems.
• Approve planned incidents.
• Represent QA on NPI team.
• Lead investigations.
• Lead site audits.
• Own site quality program procedures.
• Designee for QA manager on local CCRB.
• Review Risk Assessments.
• Support Automation activities.
• Support facilities and environmental programs.
• Review and approve Work Orders.
• Review and approve EMS/BMS alarms.
• Approve NC investigations and CAPA records.
• Approve change controls.
• Provide lot disposition and authorize lots for shipment

Education

• Masters + 2 years of directly related experience OR Bachelors + 4 years of directly related experience