Senior Specialist QA-712

ProQuality Network; Juncos (PR); On-site; USD 85,000 - 115,000; Full time

Job summary

ProQuality Network in Juncos, Puerto Rico seeks a Senior Specialist, Quality Assurance to provide technical QA oversight across manufacturing, validation, investigations, environmental characterization, and NPI activities. The role supports QA governance and acts as the designated representative for the QA Manager on the local CCRB.

The candidate will lead quality investigations, review MPs and validation reports, and collaborate with cross-functional teams to ensure compliant product releases

Qualifications

• Doctorate or relevant advanced degree with experience in QA for manufacturing
• Advanced knowledge of QA systems, validation, investigations, and NPI
• Experience supporting Change Control Review Board (CCRB) and QA governance
• Proven ability to lead cross-functional teams and manage projects
• Strong written and verbal communication, presentation skills
• Regulatory interaction experience (FDA, EMA, or equivalent)

Responsibilities

• Review and approve MPs and validation protocols and reports
• Represent QA on incident triage and NPI teams
• Lead quality investigations from initiation to closure
• Own site QA procedures and CCRB designee responsibilities
• Provide technical guidance across QA, validation, and manufacturing
• Trend and evaluate data to identify quality and compliance opportunities

Skills

Project management

Cross-functional teamwork

Regulatory knowledge

Leadership

Communication

Education

Doctorate degree

Master's degree

Bachelor's degree

Associate's degree

High school diploma

Job description

Senior Specialist QA- PRQN-712

Location: Juncos, Puerto Rico

Work Schedule: On-site | Administrative Shift

Shift Requirements: Must be available to work different shifts and/or weekends based on business needs

Position Available: 1

Contract Duration: 1 year

Important Notice

This opportunity is available exclusively to direct individual candidates. Third-party contractors, staffing vendors, and Corp-to-Corp (C2C) arrangements will not be considered.

Position Summary

Our client is seeking a Senior Specialist, Quality Assurance to serve as a technical specialist supporting the Quality Assurance program. This role will provide quality oversight across manufacturing, validation, investigations, environmental characterization, sanitary utilities, and new product introduction (NPI) activities.

The successful candidate will also support quality governance and act as a designated representative for the QA Manager on the local Change Control Review Board (CCRB).

Key Responsibilities

• Review and approve product Master Production records (MPs).
• Approve process validation protocols and reports for manufacturing processes.
• Represent Quality on incident triage teams.
• Review and approve Environmental Characterization reports.
• Support the release of sanitary utility systems.
• Review and approve planned incidents.
• Represent QA on New Product Introduction (NPI) teams.
• Lead quality investigations from initiation through completion.
• Own and maintain site Quality Assurance program procedures.
• Serve as the QA Manager's designee on the local Change Control Review Board (CCRB).
• Support cross-functional quality initiatives and provide technical guidance in areas of expertise.
• Evaluate compliance issues and support appropriate resolution.
• Perform advanced data trending and evaluation to identify quality and compliance opportunities.

Education & Experience

• Doctorate + 2 years of directly related experience
• Master's degree + 4 years of directly related experience
• Bachelor's degree + 6 years of directly related experience
• Associate's degree + 10 years of directly related experience
• High school diploma/GED + 12 years of directly related experience

Required Skills & Competencies

• Strong project management skills.
• Excellent organizational skills with the ability to manage assignments and follow them through to completion.
• Proven ability to initiate and lead cross-functional teams.
• Strong leadership, influencing, negotiation, and facilitation skills.
• Strong technical knowledge and experience within the candidate's area of expertise.
• Ability to collaborate and coordinate effectively with senior-level internal and external resources.
• Strong understanding of manufacturing and distribution processes, Quality Assurance (QA), Quality Assurance Laboratory (QAL), validation, and process development.
• Demonstrated ability to interact effectively with regulatory agencies.
• Strong proficiency with word processing, presentation, database, and spreadsheet applications.
• Excellent written and verbal communication skills.
• Strong presentation and facilitation capabilities.
• Ability to work independently while effectively collaborating with individuals at various organizational levels.
• Advanced data trending, analysis, and evaluation skills.
• Ability to assess compliance issues and support appropriate quality decisions.

Preferred Technical Experience

• Commissioning and Qualification (C&Q)
• Equipment validation
• Quality Risk Assessment and Evaluation Systems (QRAES)
• Kneat
• Good Documentation Practices (GDP)
• Change Controls
• Standard Operating Procedures (SOPs)
• Process validation
• Quality investigations
• Manufacturing and Quality systems
• Cross-functional quality programs

Candidate Profile

We are looking for a quality professional who can work independently, provide sound technical judgment, lead cross-functional initiatives, and effectively communicate with stakeholders across Manufacturing, Quality, Engineering, Validation, and other functions.