Specialist QA 3422423

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

Job summary

ProQuality Network seeks a Specialist QA to support our client’s Quality Assurance program in a regulated manufacturing environment. The role requires strong regulatory knowledge, technical expertise, and cross-functional collaboration with minimal supervision in an admin-focused hybrid setting.

The ideal candidate has a scientific or engineering background, experience with IOQ/PQ, deviations, change control, and technical writing, and can manage QA tasks and maintenance-related activities while

Qualifications

• Advanced degrees or equivalent experience in sciences or engineering.
• Experience with validations and commissioning & qualification (C&Q) of manufacturing equipment and lab bench equipment.
• Technical writing skills and knowledge of Quality Systems (Deviations, Change Control).
• Maintenance experience (Preventive Maintenance, Work Orders, Job Plans).
• Ability to work independently and lead cross-functional teams.
• Strong data trending and evaluation skills.
• Experience interacting with regulatory agencies.

Responsibilities

• Review and approve product MPs.
• Approve process validation protocols and reports for manufacturing processes.
• Lead investigations and site audits.
• Oversee the release of sanitary utility systems.
• Approve planned incidents.
• Review risk assessments.
• Support automation, facilities, and environmental programs.
• Review and approve Work Orders and EMS/BMS alarms.
• Approve nonconformance (NC) investigations and CAPA records.
• Review and approve change controls.
• Provide lot disposition and authorize lots for shipment.

Skills

Quality professional

Validations & C&Q

IOQ/PQ testing

Technical writing

Change control

Maintenance coordination

Education

Doctorate

Master’s degree + 2 years of directly related experience

Bachelor’s degree + 4 years of directly related experience

Associate’s degree + 8 years of directly related experience

High school diploma/GED + 10 years of directly related experience

Job description

Location: East of Puerto Rico (Hybrid/Remote – Administrative Shift; open to Puerto Rico residents)

Positions Available: 1

Duration: Approximately one (1) year

Summary

The Specialist QA will perform a variety of duties and responsibilities in support of our client’s Quality Assurance program, working under minimal supervision. The role requires strong technical expertise, regulatory knowledge, and the ability to support cross-functional teams in a regulated manufacturing environment.

Preferred Qualifications

• Educational background in Sciences or Engineering.
• Quality professional with experience in Validations and Commissioning & Qualification (C&Q) of manufacturing equipment and laboratory bench equipment, including IOQ, PQ, and functional testing.
• Technical writing experience and strong knowledge of Quality Systems (Deviations, Change Control).
• Experience with Maintenance activities (Preventive Maintenance, Work Orders, Job Plans review and approval).
• Skilled in reviewing technical documentation, including Validation Reports, Procedures, and Forms.

Functions

• Review and approve product MPs.
• Approve process validation protocols and reports for manufacturing processes.
• Serve as QA representative on incident triage team.
• Oversee the release of sanitary utility systems.
• Approve planned incidents.
• Lead investigations and site audits.
• Own and maintain site quality program procedures.
• Act as designee for QA Manager on local CCRB.
• Review risk assessments.
• Support automation, facilities, and environmental programs.
• Review and approve Work Orders and EMS/BMS alarms.
• Approve nonconformance (NC) investigations and CAPA records.
• Review and approve change controls.
• Provide lot disposition and authorize lots for shipment.

Education

• Doctorate 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.
• Strong project management and organizational skills, with the ability to complete assignments independently.
• Proven ability to initiate and lead cross-functional teams.
• Advanced skills in leadership, influence, and negotiation.
• In-depth knowledge of manufacturing, distribution, QA, QAL, validation, and process development processes.
• Experience interacting with regulatory agencies.
• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, databases, and spreadsheets).
• Strong communication (written and verbal), facilitation, and presentation skills.
• Ability to work independently and interact effectively across all organizational levels.
• Skilled in advanced data trending and evaluation.
• Ability to evaluate compliance issues and provide sound recommendations.
• Commitment to demonstrating our client’s Values and Leadership Practices.