Specialist QA (Regulated Industry) 3541050

ProQuality Network; Coffeyville (KS); Hybrid; USD 90,000 - 125,000; Full time

Job summary

ProQuality Network seeks a Specialist QA (Regulated Industry) for a one-year contract to provide quality oversight across manufacturing, validation, change control, and site quality systems in a regulated environment. This role supports our client’s Quality Assurance program and ensures compliance with cGMP and regulatory expectations.

The candidate will collaborate cross-functionally to support manufacturing operations, NPI initiatives, validation activities, and facility programs, driving

Qualifications

• Master’s degree with 2 years of directly related experience or
• Bachelor’s degree with 4 years of directly related experience or
• Associate degree with 8 years of directly related experience or
• High School Diploma/GED with 10 years of directly related experience

Responsibilities

• Review and approve Product Master Plans (MPs).
• Review and approve process validation protocols and reports, including PPQ activities.
• Serve as Quality representative on incident triage teams.
• Review and approve Environmental Characterization reports.
• Authorize release of sanitary utility systems.
• Review and approve planned incidents.
• Lead deviation investigations and support CAPA development.
• Lead and participate in site audits.
• Own and maintain site quality program procedures.
• Act as QA Manager designee on the local Change Control Review Board (CCRB).
• Review and approve risk assessments.
• Support Automation, Commissioning & Qualification (C&Q), PPQ, and FAT activities.
• Support facilities and environmental monitoring programs.
• Review and approve Work Orders.
• Review and approve EMS/BMS alarms.
• Review and approve Nonconformance (NC) investigations and CAPA records.
• Review and approve change control records.
• Perform lot disposition and authorize product release for shipment.

Skills

Project management

Cross-functional

Leadership

QA/QAL

Regulatory knowledge

Root cause analysis

CAPA

Documentation review

FAT/PPQ

GxP compliance

Data trending

MS Office

Communication

Team collaboration

Education

Master’s degree in related field

Bachelor’s degree in related field

Associate degree

High School Diploma/GED

Tools

None

Job description

Specialist QA (Regulated Industry) 3541050

Title: Specialist QA (Regulated Industry) – 3541050

Duration: Approximately 1 Year

Positions Available: 1

SUMMARY

ProQuality Network is seeking a Specialist QA (Regulated Industry) for a one-year contract assignment supporting our client’s Quality Assurance program. This role requires working under minimal supervision to provide quality oversight across manufacturing, validation, change control, and site quality systems within a regulated environment.

The selected candidate will ensure compliance with cGMP requirements, regulatory expectations, and internal quality standards while collaborating cross-functionally to support manufacturing operations, NPI initiatives, validation activities, and facility programs.

KEY RESPONSIBILITIES

• Review and approve Product Master Plans (MPs).
• Review and approve process validation protocols and reports, including PPQ activities.
• Serve as Quality representative on incident triage teams.
• Review and approve Environmental Characterization reports.
• Authorize release of sanitary utility systems.
• Review and approve planned incidents.
• Lead deviation investigations and support root cause analysis and CAPA development.
• Lead and participate in site audits.
• Own and maintain site quality program procedures.
• Act as QA Manager designee on the local Change Control Review Board (CCRB).
• Review and approve risk assessments.
• Support Automation, Commissioning & Qualification (C&Q), PPQ, and FAT activities.
• Support facilities and environmental monitoring programs.
• Review and approve Work Orders.
• Review and approve EMS/BMS alarms.
• Review and approve Nonconformance (NC) investigations and CAPA records.
• Review and approve change control records.
• Perform lot disposition and authorize product release for shipment.

EDUCATION & EXPERIENCE REQUIREMENTS

• Master’s degree with 2 years of directly related experience OR
• Bachelor’s degree with 4 years of directly related experience OR
• Associate degree with 8 years of directly related experience OR
• High School Diploma/GED with 10 years of directly related experience

Preferred Qualifications:

• Degree in Science or Engineering
• Experience with NPI, Change Control, Documentation Review, Validation, C&Q, PPQ, and FAT
• Experience in regulated pharmaceutical or biotechnology environments

REQUIRED COMPETENCIES & SKILLS

• Strong project management and organizational skills, with the ability to drive assignments to completion.
• Ability to initiate and lead cross-functional teams.
• Strong leadership, influencing, and negotiation skills.
• Solid knowledge of manufacturing, distribution, QA/QAL, validation, and process development.
• Experience interacting with regulatory agencies.
• Ability to assess compliance risks and implement corrective actions.
• Advanced data trending and analytical skills.
• Proficiency in Microsoft Office applications (Word, Excel, PowerPoint) and database systems.
• Strong written and verbal communication, facilitation, and presentation skills.
• Ability to work independently while collaborating effectively across all organizational levels.
• Demonstrated alignment with professional leadership practices and company values.