Specialist QA

ProQuality Network; Northern (KY); Hybrid; USD 65,000 - 90,000; Full time

Job summary

ProQuality Network is seeking a Quality Assurance Specialist to support its QA program in a hybrid Puerto Rico setting, with potential weekend availability. You will ensure compliance with regulatory requirements and internal quality standards while collaborating with cross-functional teams.

The role requires experience in NPI, validation, automation, change control, and familiarity with systems like DAI, PASx/MES, MAXIMO, SAP, and LIMS.

Qualifications

• Master’s degree with 3+ years of related experience or equivalent.
• Bachelor’s degree with 5+ years of related experience.
• Associate’s degree with 10+ years of related experience.
• High School Diploma with 12+ years of related experience.

Responsibilities

• Review and approve Master Production Records (MPs).
• Approve process validation protocols and reports.
• Serve as QA representative on incident triage teams.
• Oversee and release sanitary utility systems.
• Approve planned incidents and manage investigations.
• Lead quality investigations and site audits.
• Maintain site quality program procedures.
• Act as designee for the QA Manager during CCRB meetings.
• Review and assess Risk Assessments.
• Support Automation, Facilities, and Environmental Programs.
• Review and approve Work Orders and EMS/BMS alarms.
• Approve NC investigations and CAPA records.
• Approve and manage Change Controls.
• Provide lot disposition and lot release for shipment.

Skills

NPI experience

Validation

Automation

Change control

Risk assessment

MS Office

Education

Master’s + 3 years

Bachelor’s + 5 years

Associate + 10 years

High School + 12 years

Tools

DAI process

PASx/MES

MAXIMO

SAP

LIMS

Job description

Job Opportunity: Quality Assurance Specialist (3138088)

Location: Puerto Rico (Hybrid work – Administrative Shift)

Duration: Approximately One Year

Positions Available: 1

Summary

Our client is seeking a highly motivated Quality Assurance Specialist to support its Quality Assurance program. The ideal candidate will work under minimal supervision and be responsible for ensuring compliance with regulatory requirements and internal quality standards. This hybrid opportunity is open to residents of Puerto Rico and requires availability during weekends as needed.

Preferred Qualifications

The ideal candidate will possess:

• Experience in New Product Introduction (NPI)
• Proficiency in validation, automation, and change control processes
• Familiarity with systems such as DAI process, PASx/MES, Risk Assessment, MAXIMO, SAP, and LIMS
• Flexibility to support weekend operations

Key Responsibilities

• Review and approve Master Production Records (MPs)
• Approve process validation protocols and reports
• Serve as QA representative on incident triage teams
• Oversee and release sanitary utility systems
• Approve planned incidents
• Lead quality investigations and site audits
• Own and maintain site quality program procedures
• Act as designee for the QA Manager during local Change Control Review Board (CCRB) meetings
• Review and assess Risk Assessments
• Support Automation, Facilities, and Environmental Programs
• Review and approve Work Orders and EMS/BMS alarms
• Approve Nonconformance (NC) investigations and CAPA records
• Approve and manage Change Controls
• Provide lot disposition and lot release for shipment

Education / Licenses

Candidates must meet one of the following minimum qualifications:

• Master’s degree with 3 years of directly related experience, or
• Bachelor’s degree with 5 years of directly related experience, or
• Associate’s degree with 10 years of directly related experience, or
• High School Diploma / GED with 12 years of directly related experience

Core Competencies & Skills

• Strong project management and organizational skills
• Ability to initiate and lead cross-functional teams
• Skilled in leadership, influence, and negotiation
• Advanced knowledge of manufacturing, distribution, QA, QAL, validation, and process development
• Proven experience interacting with regulatory agencies
• Proficiency in MS Office tools: Word, Excel, PowerPoint, and database applications
• Excellent written and verbal communication, facilitation, and presentation skills
• Strong independent work ethic and ability to collaborate across all levels of the organization
• Expertise in data trending, compliance evaluation, and quality metrics analysis