QA Specialist 3445259

ProQuality Network; Northern (KY); Hybrid; USD 90,000 - 130,000; Full time

Job summary

ProQuality Network is seeking a Specialist QA to perform a wide range of Quality Assurance duties with minimal supervision. The role provides expertise in quality systems, compliance, validation, investigations, and regulatory readiness, supporting manufacturing operations and driving continuous improvement across site programs.

Preferred candidates hold advanced degrees or equivalent experience, with strong competencies in QA, process development, and regulatory interactions.

Qualifications

• Doctorate or equivalent with related experience in pharma/biotech quality.
• Advanced degree combinations with relevant experience are acceptable.
• Experience in QA, validation, compliance, investigations, and regulatory readiness.
• Strong ability to interact with regulatory agencies.

Responsibilities

• Review and approve product Master Plans (MPs).
• Approve process validation protocols and reports for manufacturing processes.
• Participate in incident triage teams as a QA representative.
• Release sanitary utility systems.
• Approve planned incidents.
• Lead investigations and site audits.
• Own and maintain site quality program procedures.
• Serve as designee for QA Manager on local CCRB.
• Review risk assessments.
• Support facilities and environmental programs.
• Review and approve Work Orders.
• Review and approve EMS/BMS alarms.
• Approve non-conformance (NC) investigations and CAPA records.
• Approve change controls.
• Provide lot disposition and authorize lots for shipment.

Skills

Project management

Cross-functional leadership

Leadership & negotiation

QA knowledge

Regulatory interactions

MS Office (Word/Excel/PowerPoint)

Written & verbal communication

Independent work

Data trending & compliance

Leadership values & practices

Education

Doctorate in a related field

Master’s degree + 2 years related experience

Bachelor’s degree + 4 years related experience

Associate’s degree + 8 years related experience

High school diploma/GED + 10 years related experience

Tools

Microsoft Office

Job description

Location: East of Puerto Rico (Open to Puerto Rico Residents)

Schedule: Non-Standard Shifts

Positions Available: 1

Period: Approximately 3 years

Summary

Our client is seeking a Specialist QA to perform a wide range of Quality Assurance duties with minimal supervision. The selected professional will provide expertise in quality systems, compliance, validation, investigations, and regulatory readiness, supporting manufacturing operations and driving continuous improvement across site programs.

Preferred Qualifications

• Bachelor's degree in Sciences or Engineering
• Experience with MES, LIMS, Maximo, and Batch Record Review

Key Functions

• Review and approve product Master Plans (MPs)
• Approve process validation protocols and reports for manufacturing processes
• Participate in incident triage teams as a Quality representative
• Release sanitary utility systems
• Approve planned incidents
• Lead investigations and site audits
• Own and maintain site quality program procedures
• Serve as designee for QA Manager on local CCRB
• Review risk assessments
• Support facilities and environmental programs
• Review and approve Work Orders
• Review and approve EMS/BMS alarms
• Approve non-conformance (NC) investigations and CAPA records
• Approve change controls
• Provide lot disposition and authorize lots for shipment

Education Requirements

• Doctorate in a related field; OR
• Master’s degree + 2 years of directly related experience; OR
• Bachelor’s degree + 4 years of directly related experience; OR
• Associate’s degree + 8 years of directly related experience; OR
• High school diploma/GED + 10 years of directly related experience

Core Competencies & Skills

• Strong project management and organizational skills, with ability to follow assignments through completion
• Proven ability to initiate and lead cross-functional teams
• Advanced leadership, influencing, and negotiation skills
• Deep knowledge in QA, validation, manufacturing, distribution, and process development
• Demonstrated ability to interact with regulatory agencies
• Proficiency in Microsoft Office (Word, Excel, PowerPoint, databases, and spreadsheets)
• Strong written and verbal communication skills, including facilitation and presentations
• Ability to work independently and effectively interact at multiple organizational levels
• Advanced skills in data trending, evaluation, and compliance issue assessments
• Commitment to demonstrating leadership values and practices

If you are looking for an exciting career opportunity where you can make a meaningful impact in the pharmaceutical/biotech industry