Specialist QA Job Northern Kentucky USA,Quality Assurance

Location: Northern

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