Senior Specialist QA PrQN 711

Frey Consulting Group; Juncos (PR); On-site; USD 90,000 - 120,000; Full time

Job summary

Frey Consulting Group is seeking a Senior Specialist QA to support the site's Quality Assurance program. The role focuses on reviewing and approving manufacturing documentation, supporting QA and manufacturing teams, and leading investigations across validation, quality systems and processes.

The ideal candidate will have advanced education in a related field and substantial experience in CSV, GMP compliance, and cross-functional collaboration.

Qualifications

• 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 Degree + 10 years of directly related experience
• High School Diploma/GED + 12 years of directly related experience

Responsibilities

• Review and approve Product Manufacturing documentation.
• Approve process validation protocols and reports for manufacturing processes.
• Lead and support quality investigations and cross-functional activities.
• Own and maintain site Quality program procedures.
• Serve as QA Manager's designee on CCRB and collaborate on regulatory matters.

Skills

Cross-functional teams

QA leadership

Documentation review

Regulatory compliance

Risk management

Data trending

Education

Doctorate

Master's Degree

Bachelor's Degree

Associate Degree

High School Diploma/GED

Tools

KNEAT

CDOCS

SCADA

TrackWise

Job description

Tittle: Senior Specialist QA - ProQN-711

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

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

Position Summary

Our client is seeking a Senior Specialist QA to serve as a technical Quality Assurance specialist supporting the site's Quality Assurance program. The role will be responsible for reviewing and approving manufacturing documentation, supporting quality and manufacturing teams, leading investigations, and providing technical expertise across validation, quality systems, and manufacturing processes.

Key Responsibilities

• Review and approve Product Manufacturing (MP) documentation.
• Approve process validation protocols and reports for manufacturing processes.
• Represent Quality Assurance on the Incident Triage Team.
• Review and approve Environmental Characterization reports.
• Support the release of sanitary utility systems.
• Review and approve planned incidents.
• Represent Quality Assurance on the New Product Introduction (NPI) team.
• Lead and support quality investigations.
• Own and maintain site Quality program procedures.
• Serve as the QA Manager's designee on the local Change Control Review Board (CCRB).
• Evaluate compliance issues and support appropriate resolution.
• Apply risk management and decision-making techniques to quality-related activities.
• Support cross-functional teams and collaborate with internal and external resources as needed.

Education & Experience

Candidates must meet one of the following educational and experience combinations:

• 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 Degree + 10 years of directly related experience
• High School Diploma/GED + 12 years of directly related experience

Core Competencies & Skills

• Excellent organizational skills, with the ability to manage assignments through completion.
• Ability to initiate and lead cross-functional teams.
• Strong leadership, influencing, negotiation, and facilitation skills.
• Strong technical knowledge within the applicable area of expertise.
• Ability to collaborate and coordinate with senior-level internal and external resources.
• Strong knowledge and experience with:
• Manufacturing and distribution processes
• Quality Assurance (QA)
• Quality Assurance Laboratories (QAL)
• Validation
• Demonstrated ability to interact with regulatory agencies.
• Strong proficiency with word processing, presentation, database, and spreadsheet applications.
• Excellent written and verbal communication skills.
• Strong presentation and facilitation skills.
• Ability to work independently while effectively collaborating with personnel at various organizational levels.
• Advanced data trending and evaluation skills.
• Ability to evaluate and address compliance issues.
• Strong knowledge of decision-making techniques.
• Strong knowledge of risk management.

Technical Knowledge & Systems

Experience or knowledge in the following areas is required:

• Facilities and Utilities Commissioning and Qualification (C&Q)
• Computer System Validation (CSV)
• Equipment Validation
• Good Documentation Practices (GDP)
• Data Integrity
• Change Controls
• Standard Operating Procedures (SOPs)
• Document revision and approval
• Syringe and vial inspection processes

Systems & Applications

• KNEAT
• CDOCS
• SCADA
• TrackWise

Additional Expectations

The successful candidate should be able to:

• Lead quality initiatives and cross-functional activities.
• Make sound, risk-based decisions in a regulated manufacturing environment.
• Evaluate data and quality trends to support business and compliance decisions.
• Effectively communicate quality requirements to multiple organizational levels.
• Work independently while managing multiple priorities and deadlines.
• Support continuous improvement and compliance within manufacturing and Quality Assurance operations.