QA Specialist (Regulated Industry) 3541955

ProQuality Network; Coffeyville (KS); Hybrid; USD 70,000 - 120,000; Full time

Job summary

ProQuality Network seeks a Quality Assurance Specialist to support its regulated manufacturing QA program with minimal supervision. The role focuses on compliance with regulatory requirements, internal procedures, and industry standards within a regulated environment.

Preferred qualifications include advanced degrees and experience in aseptic processing, validation activities, and QA systems; strong cross-functional collaboration is required to drive site quality initiatives.

Qualifications

• Master’s degree with 2+ years in life sciences or engineering or related field.
• Bachelor’s degree with 4+ years related experience; advanced degree preferred.
• Experience in regulated manufacturing environments and QA activities.

Responsibilities

• Review and approve MPs.
• Review and approve process validation protocols and reports.
• Serve as Quality representative on the incident triage team.
• Review and approve Environmental Characterization reports.
• Lead quality investigations, including non-conformance (NC) and CAPA records.
• Lead and participate in site audits.
• Own and manage site quality program procedures.
• Act as QA Manager designee on the CCRB.
• Review and approve risk assessments.
• Support automation, facilities, and environmental programs.

Skills

Cross-functional teamwork

Project management

Regulatory knowledge

Data analysis

Education

Master’s degree + 2 years of related experience

Bachelor’s degree + 4 years of related experience

Associate degree + 8 years of related experience

High School Diploma/GED + 10 years of related experience

Job description

QA Specialist (Regulated Industry) 3541955

Job Title: Specialist QA (Regulated Industry) – 3541955

Location: Hybrid/Remote (Between 1st and 2nd Shifts)

Duration: Approximately 6 Months

Open Positions: 1

Position Summary

Our client is seeking a Quality Assurance Specialist to support its Quality Assurance program under minimal supervision. The selected candidate will perform critical QA functions to ensure compliance with regulatory requirements, internal procedures, and industry standards within a regulated manufacturing environment.

This role requires strong technical expertise, cross-functional collaboration, and the ability to lead quality initiatives that support manufacturing, validation, facilities, and quality systems activities.

Preferred Qualifications

• Bachelor’s degree in Life Sciences or Engineering (advanced degree preferred)
• Experience in:
• Aseptic processing
• New Product Introduction (NPI)
• Change Control
• Factory Acceptance Testing (FAT)
• Validation activities
• Process Performance Qualification (PPQ)

Key Responsibilities

• Review and approve Master Production Records (MPs).
• Review and approve process validation protocols and reports for manufacturing processes.
• Serve as Quality representative on the incident triage team.
• Review and approve Environmental Characterization reports.
• Approve release of sanitary utility systems.
• Review and approve planned incidents.
• Lead quality investigations, including non-conformance (NC) and CAPA records.
• Lead and participate in site audits.
• Own and manage site quality program procedures.
• Act as QA Manager designee on the local Change Control Review Board (CCRB).
• Review and approve risk assessments.
• Support automation, facilities, and environmental programs.
• Review and approve Work Orders.
• Review and approve EMS/BMS alarms.
• Approve change controls.
• Provide lot disposition and authorize lots for shipment.

Education & Experience Requirements

• Master’s degree + 2 years of directly related experience; OR
• Bachelor’s degree + 4 years of directly related experience; OR
• Associate degree + 8 years of directly related experience; OR
• High School Diploma/GED + 10 years of directly related experience.
• Strong project management and organizational skills.
• Ability to initiate and lead cross-functional teams.
• Demonstrated leadership, influencing, and negotiation skills.
• Advanced knowledge of manufacturing, distribution, QA, QAL, validation, and process development.
• Experience interacting with regulatory agencies.
• Advanced data analysis, trending, and compliance evaluation skills.
• Proficiency in word processing, presentations, databases, and spreadsheets.
• Excellent written and verbal communication skills.
• Ability to work independently and effectively interact with all organizational levels.
• Strong understanding of compliance requirements in regulated environments.
• Demonstrated alignment with our client’s values and leadership practices.