Senior Specialist QA-712

Frey Consulting Group; Juncos (PR); On-site; USD 90,000 - 140,000; Full time

Job summary

Frey Consulting Group is seeking a Senior Specialist in Quality Assurance to oversee QA programs across manufacturing, validation, investigations, and NPI. You will act as QA Manager’s designee on the CCRB and guide cross-functional quality initiatives with regulatory collaboration.

The role requires strong technical QA knowledge, leadership and independent work style, with preference for candidates who can manage complex datasets and regulatory interactions.

Qualifications

• Doctorate/Master/Bachelor/Associate/HS with required years of directly related experience as specified.
• Excellent organizational and cross-functional collaboration capabilities.
• Strong leadership, negotiation and facilitation skills.
• Extensive QA/regulated manufacturing knowledge and GMP familiarity.
• Advanced data analysis, trending and problem-solving abilities.

Responsibilities

• Review and approve MPs and change control documentation.
• Approve validation protocols and reports for manufacturing processes.
• Lead quality investigations from initiation to closure.
• Represent QA on the local CCRB and QA governance activities.
• Support cross-functional quality initiatives and regulatory interactions.
• Maintain QA procedures and ensure compliance across site operations.

Skills

Organizational skills

Cross-functional leadership

Communication skills

Regulatory interaction

Data trending

Analytical thinking

Quality governance

Documentation proficiency

Stakeholder coordination

Facilitation

Education

Doctorate + 2 years

Master's degree + 4 years

Bachelor's degree + 6 years

Associate's degree + 10 years

High school diploma/GED + 12 years

Tools

Kneat

Job description

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 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.
• 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

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's degree + 10 years of directly related experience
• High school diploma/GED + 12 years of directly related experience
• 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

The ideal candidate should have hands-on experience with:

• Commissioning and Qualification (C&Q)
• 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.