Senior Specialist QA ProQN713

Frey Consulting Group; Juncos (PR); On-site; USD 90,000 - 130,000; Full time

Job summary

Frey Consulting Group is seeking a Senior Specialist QA to serve as a technical QA specialist supporting manufacturing and quality operations. The role includes reviewing and approving manufacturing documents, supporting quality events, leading investigations, and ensuring compliance across manufacturing, validation, and quality systems.

The position requires strong leadership and experience in validation, IQ/OQ/PQ, and change control, with responsibilities spanning document approval and

Qualifications

• Candidates must meet one of the listed degree/experience combinations.
• Industry experience in QA for manufacturing, validation, and quality systems.
• Strong project management and organizational skills.
• Ability to lead cross-functional teams and interact with regulators.
• Proficiency with document control and data integrity practices.

Responsibilities

• Approve process validation protocols and reports for manufacturing processes.
• Represent QA on incident triage teams and release sanitary utility systems.
• Lead quality investigations and manage site quality program procedures.
• Serve as the QA Manager's designee on the CCRB for change control.
• Provide QA support for events, new product introductions, and compliance.

Education

Doctorate + 2 years

Master’s Degree + 4 years

Bachelor’s Degree + 6 years

Associate Degree + 10 years

High School Diploma/GED + 12 years

Tools

KNEAT

CDOCS

SCADA

TrackWise

Maximo

Job description

Location: Juncos, PR — Open only to Puerto Rico Residents

Work Schedule: Onsite | Administrative Shift

Contract Duration: 1 Year

Positions Available: 1

Summary

Our client is seeking a Senior Specialist QA to serve as a technical Quality Assurance specialist supporting manufacturing and quality operations. The selected professional will review and approve manufacturing documents and product MPs, provide QA support for quality events and new product introduction activities, lead investigations, and support compliance across manufacturing, validation, and quality systems.

Preferred Qualifications

• Facilities and Utilities Commissioning and Qualification
• Computer System Validation
• Equipment Validation
• Risk Assessments and Risk Management
• KNEAT, CDOCS, SCADA, TrackWise, and Maximo
• Good Documentation Practices (GDP) and Data Integrity
• Change Controls
• Standard Operating Procedures (SOPs)
• Syringe and Vial Inspection Processes
• Document Revision and Approval

Functions

• Approve process validation protocols and reports for manufacturing processes.
• Represent Quality Assurance on incident triage teams.
• Support the release of sanitary utility systems.
• Approve planned incidents.
• Lead quality investigations.
• Own site Quality program procedures.
• Serve as the QA Manager's designee on the local Change Control Review Board (CCRB).

Education & Experience

Candidates must meet one of the following combinations:

• Doctorate + 2 years of directly related experience
• Master’s Degree + 4 years of directly related experienceli>
• 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
• Strong project management and organizational skills, including the ability to follow assignments through to completion.
• Ability to initiate and lead cross-functional teams.
• Strong leadership, influencing, and negotiation skills.
• Strong technical knowledge and expertise within the area of responsibility.
• Ability to collaborate and coordinate with higher-level external resources.
• Strong knowledge and experience in manufacturing and distribution, Quality Assurance, Quality systems, validation, and process development.
• Demonstrated ability to interact with regulatory agencies.
• Proficiency with word processing, presentation, database, and spreadsheet applications.
• Strong written and verbal communication, facilitation, and presentation skills.
• Ability to work independently and effectively interact with personnel at various organizational levels.
• Advanced data trending and evaluation skills.
• Ability to evaluate compliance issues and determine appropriate actions.
• Ability to demonstrate strong quality and leadership practices.